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Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

NCT03873168 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2021-08-30

No results posted yet for this study

Summary

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

Conditions

  • Hemostasis

Interventions

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 gynecological, urological, vascular, ENT and head and neck surgeries.

Sponsors & Collaborators

  • Biom'Up France SAS

    lead INDUSTRY

Principal Investigators

  • Tim Vilz, MD · Unversity Hospital Bonn

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2021-07-27
Completion
2021-07-27
FDA Device
Yes

Countries

  • Austria
  • France
  • Germany

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 NCT03873168 on ClinicalTrials.gov