Status:
TERMINATED
PleuraSeal Pivotal Study (US)
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Open Thoracotomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00748124
Start Date
August 1 2008
End Date
April 1 2011
Last Update
September 11 2014
Active Locations (1)
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1
Confluent Surgical
Bedford, Massachusetts, United States, 01730