NCT00748124

PleuraSeal Pivotal Study (US)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Thoracotomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-09-01
• Completion: 2011-04-01
• First posted: 2008-09-08
• Last updated: 2014-09-11

Locations

1 site across 1 country: United States