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NCT07499258 · ClinicalTrials.gov registry record
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
A clinical trial, sponsored by Axonics.
- Not yet
- Registry status
- 55
- Enrollment target
NCT07499258: Clinical Trial study, sponsored by Axonics.
NCT07499258 is a clinical trial that has not yet begun recruiting, run by Axonics. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07499258 has not yet begun recruiting, sponsored by Axonics.
- NOT YET RECRUITING
- Registry status
- 55 participants
- Enrollment target
Study Summary
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Primary Outcome
Short-term FI improvement demonstrated by Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Interventions
- DEVICE Axonics SNM System INS Model 5101 (R20)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2026-07 |
| Est. Completion | 2029-12 |
What is known before NCT07499258 opens enrollment
NCT07499258 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Axonics SNM System INS Model 5101 (R20) is the first listed.
NCT07499258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07499258 about?
NCT07499258 is a clinical study titled "Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence". Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
What is the current status of trial NCT07499258?
This trial is currently not yet recruiting. The enrollment target is 55 participants. The study started on 2026-07. Estimated completion is 2029-12.
What interventions are being tested in trial NCT07499258?
The interventions under investigation include: Axonics SNM System INS Model 5101 (R20) (DEVICE).
Who is sponsoring clinical trial NCT07499258?
This trial is sponsored by Axonics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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