RecruitingNot ApplicableNCT07270380

Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.

A Multi-center, Single-arm, Historically Controlled Pivotal Trial, to Assess the Safety and Effectiveness of Genex G as Part of the Surgical Treatment of Osteomyelitis of the Extremities.

Sponsor

Biocomposites Ltd

Enrollment

139 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Osteomyelitis

Summary

The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called genex with gentamicin (genex G) for people with osteomyelitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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