PleuraSeal Pivotal Study (US)

Integra LifeSciences

Status and phase: Terminated; Phase 3

Conditions: Open Thoracotomy

Treatments: Device: PleuraSeal Sealant System; Procedure: Standard Tissue Closure Techniques

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748124

LUN-06-001

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

PleuraSeal Sealant Device

Experimental group

Treatment:

Procedure: Standard Tissue Closure Techniques

Device: PleuraSeal Sealant System

Control

Other group

Treatment:

Procedure: Standard Tissue Closure Techniques