NCT00562302

Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure

A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: Angiotech Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.

Conditions

• Pneumothorax

Interventions

Type	Name	Description
DEVICE	Bio-Seal Plug	Deployment of the Bio-Seal plug in needle track

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2007-11-22
• Last updated: 2013-03-27
• Results posted: 2013-03-27

Locations

18 sites across 1 country: United States