PleuraSeal Pivotal Study (US)

Open Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748124
• Other study ID #: LUN-06-001
• Status: Terminated
• Phase: Phase 3
• First received: September 4, 2008
• Last updated: September 4, 2014
• Start date: August 2008
• Est. completion date: April 2011

Study information

• Verified date: September 2014
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 230
• Est. completion date: April 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Open Thoracotomy

Intervention

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

Locations

Country	Name	City	State
United States	Confluent Surgical	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.		75 days	Yes