PleuraSeal Pivotal Study (US)

Stopped early · Phase 3

Conditions studied: Open Thoracotomy

In brief

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.

Key facts

Study ID

NCT00748124

Run by

Integra LifeSciences Corporation

People needed

230

Starts

2008-08-01

Expected to finish

2011-04-01

Last updated by the study team

2014-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• Confluent Surgical — Bedford, Massachusetts, United States

Full record on ClinicalTrials.gov

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