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Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

NCT03772912 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-12-14

No results posted yet for this study

Summary

The purpose of this post-market observational registry is to collect additional data on the safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty procedures.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

DEVICE

HEMOBLAST Bellows

The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

Sponsors & Collaborators

  • Biom'Up France SAS

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

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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 NCT03772912 on ClinicalTrials.gov