deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm 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

Sponsor: Angiotech Pharmaceuticals

Conditions Pneumothorax
Interventions Bio-Seal Plug
Updated 8 times since 2017 Last updated: Mar 26, 2013 Started: Apr 30, 2005 Primary completion: Jun 30, 2008 Completion: Aug 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Pneumothorax and is currently completed. Angiotech Pharmaceuticals leads this study, which shows 8 recorded versions since 2005 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Angiotech Pharmaceuticals
Data source: Angiotech Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .