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PleuraSeal Pivotal Study (US)

This study has been terminated.
(Interim analysis results were not supportive of primary endpoint)
Information provided by (Responsible Party):
Integra LifeSciences Corporation Identifier:
First received: September 4, 2008
Last updated: September 4, 2014
Last verified: September 2014
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 Blind (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


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

Inclusion Criteria:

  • Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00748124

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

Responsible Party: Integra LifeSciences Corporation Identifier: NCT00748124     History of Changes
Other Study ID Numbers: LUN-06-001
Study First Received: September 4, 2008
Last Updated: September 4, 2014 processed this record on April 26, 2017