PleuraSeal Pivotal Study (US)

This study has been terminated.
(Interim analysis results were not supportive of primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00748124
First received: September 4, 2008
Last updated: February 22, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Covidien:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748124

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

No publications provided

Responsible Party: Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier: NCT00748124     History of Changes
Other Study ID Numbers: LUN-06-001
Study First Received: September 4, 2008
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 24, 2014