Phase 3
N=339
Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Pneumothorax
Bottom Line
View on ClinicalTrials.gov: NCT00562302 ↗Enrolled (actual)
339
Serious AEs
0.9%
Results posted
Mar 2013
Primary outcome: Primary: Incidence Rate of Treatment Success — 126; 94 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bio-Seal Plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Angiotech Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Treatment Success |
126; 94 | — |
| SECONDARY Incidence of Chest Tube Placement |
6; 18 | — |
| SECONDARY Time to Ambulation |
3.3; 3.8 | — |
| SECONDARY Incidence of Hospital Admissions for Pneumothorax |
16; 23 | — |
| SECONDARY Incidence of Adverse Events Related to the Procedure and Device Effects |
43; 74 | — |
| SECONDARY Number of Participants With Additional Chest X-rays Needed |
29; 52 | — |
| SECONDARY Participants Discharged Beyond Hospital's Standard of Care |
8; 18 | — |
| SECONDARY Incidence of Adverse Events |
31; 36 | — |
Summary
BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
Eligibility Criteria
Inclusion Criteria
- The patient must meet all medical conditions for lung biopsy;
- The patient must be at least 18 years of age;
- The patient, or legal representative, must understand and provide written consent for the procedure;
- The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.
Exclusion Criteria
- Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
- Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
- Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
- Patients who are uncooperative or cannot follow instructions.
- Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.
Data sourced from ClinicalTrials.gov (NCT00562302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.