PleuraSeal Pivotal Study (US)

Phase 3

Terminated

• Conditions: Open Thoracotomy
• Interventions: Device: PleuraSeal Sealant System; Procedure: Standard Tissue Closure Techniques

• Registration Number: NCT00748124
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Primary Completion: 2010-09
• Study Completion: 2011-04
• Disposition First Submitted: 2013-02-22
• Disposition First Submitted QC: 2013-02-22
• Disposition First Posted: 2013-02-28
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PleuraSeal Sealant Device	PleuraSeal Sealant System	-
PleuraSeal Sealant Device	Standard Tissue Closure Techniques	-
Control	Standard Tissue Closure Techniques	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.	75 days

Trial Locations

Locations (1)

Confluent Surgical; 🇺🇸 Bedford, Massachusetts, United States