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NCT00748124 · ClinicalTrials.gov registry record · Phase 3
PleuraSeal Pivotal Study (US)
A Phase 3 study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT00748124: Clinical Trial Phase 3 study, sponsored by Integra LifeSciences Corporation.
NCT00748124 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 230 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00748124, a Phase 3 study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.
Interventions
- PROCEDURE Standard Tissue Closure Techniques
- DEVICE PleuraSeal Sealant System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
Why NCT00748124 stopped before completion
NCT00748124 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Tissue Closure Techniques is the first listed.
NCT00748124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00748124 about?
NCT00748124 is a clinical study titled "PleuraSeal Pivotal Study (US)". To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure t...
What is the current status of trial NCT00748124?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2008-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00748124?
The interventions under investigation include: Standard Tissue Closure Techniques (PROCEDURE), PleuraSeal Sealant System (DEVICE).
Who is sponsoring clinical trial NCT00748124?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00748124's enrollment target sits among peer trials
230 1304th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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