Trials / Completed
CompletedNCT03873181
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Laparoscopic Abdominal, Gynecological and Urological Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 102 (actual)
- Sponsor
- Biom'Up France SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
Detailed description
A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery. Up to 100 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HEMOBLAST™ Bellows | Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in laparoscopic abdominal, gynecological, or urological surgeries. |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2020-08-26
- Completion
- 2020-08-26
- First posted
- 2019-03-13
- Last updated
- 2020-12-04
Locations
8 sites across 3 countries: Austria, France, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03873181. Inclusion in this directory is not an endorsement.