Trials / Completed
CompletedNCT03450265
Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection
A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 279 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hemopatch | Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults. |
| DEVICE | Tachosil | Applied according to the current instruction for use (IFU). |
Timeline
- Start date
- 2018-06-26
- Primary completion
- 2019-07-09
- Completion
- 2019-07-09
- First posted
- 2018-03-01
- Last updated
- 2020-04-06
Locations
14 sites across 2 countries: Italy, Spain
Source: ClinicalTrials.gov record NCT03450265. Inclusion in this directory is not an endorsement.