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

NCT07270380 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Osteomyelitis

Interventions

DEVICE

genex with gentamicin (genex G)

genex with gentamicin will be implanted during debridement surgery

Sponsors & Collaborators

  • Biocomposites Ltd

    lead INDUSTRY

Principal Investigators

  • Keira Watts, PHD · Biocomposites Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-10-31
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

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 NCT07270380 on ClinicalTrials.gov