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Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study sites: 4 to 5
  2. Notable Primary endpoints: details revised at 2 of 2 entries Show 5 more changesShow less
    • Primary completion moved earlier from Dec 2027 to Aug 2027
    • Study completion moved earlier from Dec 2029 to Jun 2028
    • Study sites: 2 to 4
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 4 entries
  3. Notable Recruitment opened
    • Start date changed from estimate of Jul 2026 to Jul 2, 2026
    • Site details revised at 2 of 2 sites
    v6
  4. Minor Study sites: 1 to 2
    • Start date: Jun 2026 to Jul 2026
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: May 1, 2026 to Jun 2026
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2027 to Dec 2027
    • Study completion date: Dec 30, 2029 to Dec 2029
    v3
  2. Minor Secondary endpoints: details revised at 3 of 4 entriesv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
5 trials monitored
See 1 trial at risk
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Trial Details
NCT Number NCT07499258
Lead Sponsor Axonics, Inc.
Conditions
(from sponsor)
Fecal Incontinence
Related terms Fecal Incontinence
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov