PleuraSeal Pivotal Study (US)
This study has been terminated.
(Interim analysis results were not supportive of primary endpoint)
Sponsor:
Confluent Surgical
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00748124
First received: September 4, 2008
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Open Thoracotomy |
Device: PleuraSeal Sealant System Procedure: Standard Tissue Closure Techniques |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Further study details as provided by Covidien:
Primary Outcome Measures:
- Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 230 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PleuraSeal Sealant Device |
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
|
| Control |
Procedure: Standard Tissue Closure Techniques
Standard tissue closure techniques (sutures/ staples) alone
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Covidien ( Confluent Surgical ) |
| ClinicalTrials.gov Identifier: | NCT00748124 History of Changes |
| Other Study ID Numbers: | LUN-06-001 |
| Study First Received: | September 4, 2008 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013