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HEMOBLAST Pivotal Clinical Investigation

NCT02780869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-12-27

Study results available
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Summary

The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.

Conditions

  • Hemostasis

Interventions

DEVICE

HEMOBLAST Bellows

DEVICE

Absorbable gelatin sponge, USP with thrombin

Sponsors & Collaborators

  • Biom'Up France SAS

    lead INDUSTRY

Principal Investigators

  • William Chapman, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-18
Primary Completion
2017-02-01
Completion
2017-03-27

Countries

  • United States

Study Locations

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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 NCT02780869 on ClinicalTrials.gov