Trials / Completed
CompletedNCT02780869
HEMOBLAST Pivotal Clinical Investigation
Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Biom'Up France SAS · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HEMOBLAST Bellows | |
| DEVICE | Absorbable gelatin sponge, USP with thrombin |
Timeline
- Start date
- 2016-07-18
- Primary completion
- 2017-02-01
- Completion
- 2017-03-27
- First posted
- 2016-05-24
- Last updated
- 2018-12-27
- Results posted
- 2018-11-07
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02780869. Inclusion in this directory is not an endorsement.