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PleuraSeal Pivotal Study (US)

This study has been terminated.
(Interim analysis results were not supportive of primary endpoint)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748124
First Posted: September 8, 2008
Last Update Posted: September 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Integra LifeSciences Corporation
  Purpose
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.

Condition Intervention Phase
Open Thoracotomy Device: PleuraSeal Sealant System Procedure: Standard Tissue Closure Techniques Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. [ Time Frame: 75 days ]

Enrollment: 230
Study Start Date: August 2008
Study Completion Date: April 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control Procedure: Standard Tissue Closure Techniques
Standard tissue closure techniques (sutures/ staples) alone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748124


Locations
United States, Massachusetts
Confluent Surgical
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00748124     History of Changes
Other Study ID Numbers: LUN-06-001
First Submitted: September 4, 2008
First Posted: September 8, 2008
Last Update Posted: September 11, 2014
Last Verified: September 2014