Trial Outcomes & Findings for Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy (NCT NCT00553436)
NCT ID: NCT00553436
Last Updated: 2010-04-27
Results Overview
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
At The Time of Surgery
Results posted on
2010-04-27
Participant Flow
Single Center, hospital based surgical suite. Enrollment from 20 August 2007 to 09 April 2009.
Non-randomized. Patients were considered for enrollment based on inclusion / exclusion criteria and were offered the opportunity for enrollment. Those that signed informed consent were enrolled.
Participant milestones
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Overall Study
Conversion to another procedure
|
1
|
Baseline Characteristics
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
Baseline characteristics by cohort
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 Participants
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
65 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At The Time of SurgeryPopulation: All enrolled subjects were analyzed
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
Outcome measures
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 Participants
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)
|
6 participants
|
SECONDARY outcome
Timeframe: 3 month follow-upThe total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.
Outcome measures
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 Participants
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.
|
6 participants
|
SECONDARY outcome
Timeframe: 3 month follow-upPopulation: All enrolled subjects were analyzed
Outcome measures
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 Participants
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition
|
6 Participants
|
Adverse Events
Enrolled Subjects Treated With Tissue Apposition System (TAS)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 participants at risk
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Cardiac disorders
Chest Pain
|
14.3%
1/7 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Enrolled Subjects Treated With Tissue Apposition System (TAS)
n=7 participants at risk
All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
|
|---|---|
|
General disorders
Abdominal Pain
|
85.7%
6/7 • Number of events 7 • 3 months
|
|
General disorders
Abdominal Tenderness
|
57.1%
4/7 • Number of events 4 • 3 months
|
|
General disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
scratch
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
hemoglobin low
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Cardiac disorders
sinus bradycardia
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
General disorders
Abdominal cramp
|
42.9%
3/7 • Number of events 4 • 3 months
|
|
Gastrointestinal disorders
blood in stool
|
28.6%
2/7 • Number of events 2 • 3 months
|
|
Skin and subcutaneous tissue disorders
dry mouth
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Nervous system disorders
headache
|
42.9%
3/7 • Number of events 3 • 3 months
|
|
General disorders
lower abdominal pain
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
numbness lips
|
28.6%
2/7 • Number of events 2 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder discomfort
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
tingling lips
|
28.6%
2/7 • Number of events 2 • 3 months
|
|
General disorders
pain abdominal
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
granulation tissue
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
pain in toe
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
application site bruise
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
hematoma
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
28.6%
2/7 • Number of events 2 • 3 months
|
|
Skin and subcutaneous tissue disorders
injection site itching
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
low hemoglobin
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Cardiac disorders
atrial fibrillation
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Vascular disorders
abdominal aortic aneurysm
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
General disorders
dry nose
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
RBC low
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
General disorders
soreness corner of mouth
|
28.6%
2/7 • Number of events 2 • 3 months
|
|
Surgical and medical procedures
suture line inflammation
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
abdominal bloating
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
General disorders
tenderness
|
14.3%
1/7 • Number of events 1 • 3 months
|
|
Surgical and medical procedures
polyp removal
|
14.3%
1/7 • Number of events 1 • 3 months
|
Additional Information
Amy Mahanes, Clinical Research Associate II
Ethicon Endo-Surgery, Inc
Phone: 513-337-8366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60