Trial Outcomes & Findings for Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee (NCT NCT00314236)
NCT ID: NCT00314236
Last Updated: 2015-12-18
Results Overview
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
12 months
Results posted on
2015-12-18
Participant Flow
Subjects were recruited from May 04, 2006 to January 2009 from orthopaedic surgeon referrals across 24 centers across Canada, Europe, and South Korea.
Subjects were stratified by site and lesion type (acute/chronic) to address possible repair differences. Final eligibility and lesion type were determined during diagnostic arthroscopy at treatment visit, subjects were randomized to BST-CarGel or MFX treatment using a computer-generated randomization schedule to ensure a 1:1 ratio within each site.
Participant milestones
| Measure |
Experimental
BST-CarGel applied to a Microfractured lesion
|
Control
Microfracture alone
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Baseline characteristics by cohort
| Measure |
Experimental
n=41 Participants
BST-CarGel applied to a Microfractured lesion
|
Control
n=39 Participants
Microfracture alone
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.
Outcome measures
| Measure |
Experimental
n=41 Participants
BST-CarGel applied to a Microfractured lesion
|
Control
n=37 Participants
Microfracture alone
|
|---|---|---|
|
Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
|
92.81 Percentage of lesion fill
Standard Error 1.98
|
85.22 Percentage of lesion fill
Standard Error 2.08
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).
Outcome measures
| Measure |
Experimental
n=41 Participants
BST-CarGel applied to a Microfractured lesion
|
Control
n=37 Participants
Microfracture alone
|
|---|---|---|
|
Repair Cartilage T2 Relaxation Time
|
70.46 milliseconds
Standard Error 4.49
|
85.04 milliseconds
Standard Error 4.89
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans.
The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.
Outcome measures
| Measure |
Experimental
n=41 Participants
BST-CarGel applied to a Microfractured lesion
|
Control
n=37 Participants
Microfracture alone
|
|---|---|---|
|
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Pain
|
-16.16 Units on a scale
Standard Error 1.16
|
-16.91 Units on a scale
Standard Error 1.21
|
|
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Stiffness
|
-5.97 Units on a scale
Standard Error 0.68
|
-6.56 Units on a scale
Standard Error 0.71
|
|
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Function
|
-55.96 Units on a scale
Standard Error 4.24
|
-60.59 Units on a scale
Standard Error 4.41
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary.
Outcome measures
| Measure |
Experimental
n=41 Participants
BST-CarGel applied to a Microfractured lesion
|
Control
n=39 Participants
Microfracture alone
|
|---|---|---|
|
Frequency of Adverse Events Between Study Groups
|
97.6 Percentage of participants
|
92.3 Percentage of participants
|
Adverse Events
Experimental
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=41 participants at risk
BST-CarGel applied to a Microfractured lesion
|
Control
n=39 participants at risk
Microfracture alone
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
100.0%
1/1 • Number of events 2 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
deep vein thrombosis
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Respiratory, thoracic and mediastinal disorders
pleurisy
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
chest pain
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
diarrhoea
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
2.4%
1/41 • Number of events 1 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
Other adverse events
| Measure |
Experimental
n=41 participants at risk
BST-CarGel applied to a Microfractured lesion
|
Control
n=39 participants at risk
Microfracture alone
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
68.3%
28/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
64.1%
25/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
14.6%
6/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
7.7%
3/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
joint stiffness
|
12.2%
5/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
10.3%
4/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
12.2%
5/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
muscular spasms
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
arthropathy
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
chest wall pain
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
exostosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
hemarthrosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
joint ankylosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
muscle atrophy
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
myositis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
osteochondrosis
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
plantar fasciitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
procedural pain
|
31.7%
13/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
30.8%
12/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
post-procedural nausea
|
12.2%
5/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
burns second degree
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
epicondylitis
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
frostbite
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
incision site complication
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
joint dislocation
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
joint injury
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
joint sprain
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
post-procedural edema
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
road traffic accident
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Injury, poisoning and procedural complications
seroma
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
headache
|
12.2%
5/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
12.8%
5/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
dizziness
|
7.3%
3/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
tremor
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
balance disorder
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
burning sensation
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
carpal tunnel syndrome
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
complex regional pain syndrome
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
convulsion
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
disturbance in attention
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
hyperesthesia
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
loss of consciousness
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Nervous system disorders
syncope vasovagal
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
chills
|
7.3%
3/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
pyrexia
|
9.8%
4/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
influenza-like illness
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
edema peripheral
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
adverse drug reaction
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
chest pain
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
discomfort
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
drug intolerance
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
feeling hot
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
feeling of relaxation
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
injection site bruising
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
injection site pain
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
malaise
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
General disorders
pain
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
nasopharyngitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
12.8%
5/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
sinusitis
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
7.7%
3/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
upper respiratory tract infection
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
5.1%
2/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
bronchitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
infected insect bite
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
clostridium colitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
escherichia infection
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
gastroenteritis viral
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
gingival infection
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
herpes zoster
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
influenza
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
laryngitis
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
onychomycosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
pharyngitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
skin infection
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
stitch abscess
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
tinea pedis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
nausea
|
17.1%
7/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
vomiting
|
12.2%
5/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
diarrhea
|
9.8%
4/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
constipation
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
abdominal pain lower
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
abdominal pain upper
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
crohn's disease
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
dyspepsia
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
7.3%
3/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
excessive granulation tissue
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
keloid scar
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
pityriasis rosea
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
rosacea
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
seborrheic dermatitis
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
hypertension
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
circulatory depression
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
deep vein thrombosis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
hypotension
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
peripheral coldness
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
thrombophlebitis
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
blood pressure decreased
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
blood pressure increased
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
body temperature increased
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Vascular disorders
weight increased
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Blood and lymphatic system disorders
anemia
|
4.9%
2/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Psychiatric disorders
anxiety
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Psychiatric disorders
hallucination
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Renal and urinary disorders
polyuria
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Immune system disorders
drug hypersensitivity
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Metabolism and nutrition disorders
podagra
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
|
2.4%
1/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
0.00%
0/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
|
Reproductive system and breast disorders
cervical dysplasia
|
0.00%
0/41 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
2.6%
1/39 • AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
|
Additional Information
Alberto Restrepo, MD, Director of Medical and Clinical Affairs
Piramal Healthcare (Canada) Limited
Phone: 450-686-2437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restriction on the Institution/PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is \> 60 days but ≤ 90 days from time submitted to sponsor for review. Sponsor can require changes to communication. Control over publication/presentation shall be extended for maximum of 2 years after termination of Trial, after which Institution/PI shall be free to publish/present without restraint.
- Publication restrictions are in place
Restriction type: OTHER