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

A

Angiotech Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Pneumothorax

Treatments

Device: Bio-Seal Plug

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562302
BS-1053

Details and patient eligibility

About

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

Full 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.

Enrollment

339 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

339 participants in 2 patient groups

Bio-Seal Group
Experimental group
Description:
Bio-Seal Plug Implanted
Treatment:
Device: Bio-Seal Plug
Control Group
No Intervention group
Description:
Control group with no intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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