Trials / Completed
CompletedNCT02668978
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 170 (actual)
- Sponsor
- Quirón Madrid University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hemopatch™ Sealing Hemostat | Hemopatch™ application over lung resection areas |
| PROCEDURE | Standard surgical technique | Lung resuturing or restapling |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2019-08-31
- Completion
- 2019-08-31
- First posted
- 2016-01-29
- Last updated
- 2019-09-04
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02668978. Inclusion in this directory is not an endorsement.