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Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery

NCT03873181 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2020-12-04

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 laparoscopic abdominal, gynecological, and urological 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 laparoscopic abdominal, gynecological, or urological surgeries.

Sponsors & Collaborators

  • Biom'Up France SAS

    lead INDUSTRY

Principal Investigators

  • Tim Vilz, MD · University Hospital, Bonn

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2020-08-26
Completion
2020-08-26
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 NCT03873181 on ClinicalTrials.gov