NCT03772912

Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Biom'Up France SAS · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

A maximum of 100 subjects will be enrolled at up to 5 centers in the United States. Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-12-12
• Last updated: 2018-12-14

Regulatory

• FDA-regulated device study