MedTrace Logo

ACCEL Absorbable Hemostat

NCT04728087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-07-17

No results posted yet for this study

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

  • Hemostasis

Interventions

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® .

Sponsors & Collaborators

  • Hemostasis, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2024-11-30
Completion
2025-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728087 on ClinicalTrials.gov