Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
NCT03770195 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2018-12-14
Summary
The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.
Conditions
- Abdominoplasty
Interventions
- DEVICE
-
HEMOBLAST Bellows
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
Sponsors & Collaborators
-
Biom'Up France SAS
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-13
- Primary Completion
- 2018-12-12
- Completion
- 2018-12-12
- FDA Device
- Yes
Countries
- United States
Study Locations
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