Trial Outcomes & Findings for Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure (NCT NCT00562302)
NCT ID: NCT00562302
Last Updated: 2013-03-27
Results Overview
Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
339 participants
Primary outcome timeframe
30 days
Results posted on
2013-03-27
Participant Flow
Participant milestones
| Measure |
Bio-Seal Group
Bio-Seal Plug Implanted
|
Control Group
Control group with no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
169
|
|
Overall Study
COMPLETED
|
150
|
137
|
|
Overall Study
NOT COMPLETED
|
20
|
32
|
Reasons for withdrawal
| Measure |
Bio-Seal Group
Bio-Seal Plug Implanted
|
Control Group
Control group with no intervention
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Adverse Event
|
0
|
6
|
|
Overall Study
Non-compliance
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lung resection prior to study completion
|
7
|
7
|
|
Overall Study
Not stated
|
1
|
4
|
Baseline Characteristics
Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Baseline characteristics by cohort
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.1 Years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
67.2 Years
STANDARD_DEVIATION 12.38 • n=7 Participants
|
66.7 Years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
History of Smoking
Yes
|
145 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
History of Smoking
No
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Per Protocol Population
Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).
Outcome measures
| Measure |
Bio-Seal Group
n=150 Participants
Bio-Seal Plug Implanted
|
Control Group
n=137 Participants
Control group with no intervention
|
|---|---|---|
|
Incidence Rate of Treatment Success
|
126 participants
|
94 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intent to treat Population
A chest tube is the definitive initial treatment of a pneumothorax.
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Incidence of Chest Tube Placement
|
6 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intent to Treat Population
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Time to Ambulation
|
3.3 Hours
Standard Deviation 4.63
|
3.8 Hours
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: 30 dayPopulation: Intent to treat Population
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Incidence of Hospital Admissions for Pneumothorax
|
16 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 30 DayPopulation: Intent to Treat Patients
Anticipated, device-related adverse events that were defined in the original protocol.
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Incidence of Adverse Events Related to the Procedure and Device Effects
|
43 participants
|
74 participants
|
SECONDARY outcome
Timeframe: 30 dayPopulation: Intent to Treat Population
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Number of Participants With Additional Chest X-rays Needed
|
29 participants
|
52 participants
|
SECONDARY outcome
Timeframe: 30-dayPopulation: Intent to Treat Population
Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Participants Discharged Beyond Hospital's Standard of Care
|
8 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intent to Treat Population
Any treatment emergent adverse events (not considered device related by the investigators).
Outcome measures
| Measure |
Bio-Seal Group
n=170 Participants
Bio-Seal Plug Implanted
|
Control Group
n=169 Participants
Control group with no intervention
|
|---|---|---|
|
Incidence of Adverse Events
|
31 participants
|
36 participants
|
Adverse Events
Bio-Seal Group
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bio-Seal Group
n=170 participants at risk
Bio-Seal Plug Implanted
|
Control Group
n=169 participants at risk
Control group with no intervention
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HEMORRHAGE
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Cardiac disorders
SYNCOPE
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Bio-Seal Group
n=170 participants at risk
Bio-Seal Plug Implanted
|
Control Group
n=169 participants at risk
Control group with no intervention
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
4/170 • Number of events 4 • 30 days
|
5.3%
9/169 • Number of events 9 • 30 days
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
5/170 • Number of events 5 • 30 days
|
3.0%
5/169 • Number of events 5 • 30 days
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.59%
1/170 • Number of events 1 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
General disorders
STOMATITIS
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
General disorders
ASTHENIA
|
0.59%
1/170 • Number of events 1 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
General disorders
ADVERSE DRUG REACTION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Blood and lymphatic system disorders
CHEST PAIN
|
1.2%
2/170 • Number of events 2 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Blood and lymphatic system disorders
PYREXIA
|
1.8%
3/170 • Number of events 3 • 30 days
|
0.00%
0/169 • 30 days
|
|
Blood and lymphatic system disorders
ENERGY INCREASED
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
INFUSION SITE PAIN
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Blood and lymphatic system disorders
PUNCTURE SITE PAIN
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
FALL
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
HAEMOTHORAX
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
INCISION SITE COMPLICATION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Infections and infestations
PNEUMONIA
|
0.59%
1/170 • Number of events 1 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
MALIGNANT NEOPLASM PROGRESSION
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.59%
1/170 • Number of events 1 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Investigations
WEIGHT DECREASED
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.59%
1/170 • Number of events 1 • 30 days
|
2.4%
4/169 • Number of events 4 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.2%
2/170 • Number of events 2 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Nervous system disorders
HEADACHE
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Nervous system disorders
DIZZINESS
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
2.4%
4/170 • Number of events 4 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
1.2%
2/170 • Number of events 2 • 30 days
|
0.00%
0/169 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY GRANULOMA
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.2%
2/170 • Number of events 2 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.00%
0/169 • 30 days
|
|
Vascular disorders
SUPERIOR VENA CAVAL OCCLUSION
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Immune system disorders
Allergic reaction to anesthesia/drugs
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Bleeding at puncture site
|
0.59%
1/170 • Number of events 1 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema (subcutaneous)
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.9%
5/170 • Number of events 5 • 30 days
|
3.0%
5/169 • Number of events 5 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
17.6%
30/170 • Number of events 31 • 30 days
|
31.4%
53/169 • Number of events 53 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fluid
|
0.59%
1/170 • Number of events 1 • 30 days
|
3.0%
5/169 • Number of events 5 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain with pneumothorax
|
4.1%
7/170 • Number of events 7 • 30 days
|
7.7%
13/169 • Number of events 13 • 30 days
|
|
Cardiac disorders
Chest pain without pneumothorax
|
5.3%
9/170 • Number of events 11 • 30 days
|
6.5%
11/169 • Number of events 11 • 30 days
|
|
Injury, poisoning and procedural complications
Puncture site bruising
|
0.00%
0/170 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
General disorders
Fatigue
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Coughing with Blood
|
1.8%
3/170 • Number of events 5 • 30 days
|
1.2%
2/169 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Altered lung function
|
0.00%
0/170 • 30 days
|
0.59%
1/169 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place