PleuraSeal Pivotal Study (US)

September 4, 2014 updated by: Integra LifeSciences Corporation

A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Confluent Surgical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Procedure: Standard Tissue Closure Techniques
Standard tissue closure techniques (sutures/ staples) alone
Experimental: PleuraSeal Sealant Device
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
Time Frame: 75 days
75 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • LUN-06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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