# PleuraSeal Pivotal Study (US)

> **NCT00748124** · PHASE3 · TERMINATED · sponsor: **Integra LifeSciences Corporation** · enrollment: 230 (actual)

## Conditions studied

- Open Thoracotomy

## Interventions

- **DEVICE:** PleuraSeal Sealant System
- **PROCEDURE:** Standard Tissue Closure Techniques

## Key facts

- **NCT ID:** NCT00748124
- **Lead sponsor:** Integra LifeSciences Corporation
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2008-08
- **Primary completion:** 2010-09
- **Final completion:** 2011-04
- **Target enrollment:** 230 (ACTUAL)
- **Why stopped:** Interim analysis results were not supportive of primary endpoint
- **Last updated:** 2014-09-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00748124

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00748124, "PleuraSeal Pivotal Study (US)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00748124. Licensed CC0.

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