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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 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 230 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00748124
The ClinicalTrials.gov registry entry for NCT00748124 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Tissue Closure Techniques is the first listed.
NCT00748124 reports 0 study locations.
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.
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