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PleuraSeal Pivotal Study (US)

NCT00748124 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2014-09-11

No results posted yet for this 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.

Conditions

  • Open Thoracotomy

Interventions

DEVICE

PleuraSeal Sealant System

Lung Sealant Device + standard tissue closing techniques (sutures/staples)

PROCEDURE

Standard Tissue Closure Techniques

Standard tissue closure techniques (sutures/ staples) alone

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-09-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748124 on ClinicalTrials.gov