Trials / Unknown
UnknownNCT04728087
ACCEL Absorbable Hemostat
ACCEL® Absorbable Hemostat Powder Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- Sponsor
- Hemostasis, LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue surgery, when control of oozing to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACCEL® Absorbable Hemostat Powder | Up to 2 bellows (10 grams nominal) of ACCEL® |
| DEVICE | Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) | Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® . |
Timeline
- Start date
- 2021-10-26
- Primary completion
- 2024-11-30
- Completion
- 2025-01-30
- First posted
- 2021-01-28
- Last updated
- 2024-07-17
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04728087. Inclusion in this directory is not an endorsement.