Trials / Completed
CompletedNCT00704171
PleuraSeal Post Market Study (Europe)
Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard Tissue Closure Techniques | Standard Tissue Closure Techniques (sutures and staples only) |
| DEVICE | PleuraSeal Lung Sealant System |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-06-24
- Last updated
- 2016-10-27
- Results posted
- 2010-03-15
Locations
9 sites across 6 countries: United States, Austria, Belgium, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00704171. Inclusion in this directory is not an endorsement.