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

Study acronym: ADOPT GG
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 1 → 4 locationsv6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date: Apr 2026 to Jun 2026
    • Eligibility criteria expanded, about 7 words
    v4
  4. Recruitment opened
    • Study sites: 0 to 1
    v3
  5. Start date: Jan 2026 to Apr 2026
    • Primary completion date: Jul 2027 to Oct 2027
    • Study completion date: Jul 2028 to Oct 2028
    • Eligibility criteria expanded, about 35 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07270380
Lead Sponsor Biocomposites Ltd
Conditions
(from sponsor)		 Osteomyelitis
Related terms Osteomyelitis
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov