Trials / Withdrawn
WithdrawnNCT04471350
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Biom'Up France SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
Detailed description
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.
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 spine surgery. |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2022-06-01
- Completion
- 2022-08-01
- First posted
- 2020-07-15
- Last updated
- 2021-08-30
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04471350. Inclusion in this directory is not an endorsement.