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

Part of paid clinical trials in New York, New York.

Sponsor
Axonics, Inc.
Study ID
NCT07499258
Status
Recruiting
Apply to this trial

Conditions

  • Fecal Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axonics SNM System INS Model 5101 (R20) — DEVICE
    Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.

Study Details

Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.

Key Dates

First listed
Mar 30, 2026
Start date
Jul 2, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: Fecal Incontinence
    Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.

Primary Outcome Measure

Performance/effectiveness - Improvement in Quality of Life scoring (FI) [ Time Frame: 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Emily Breneisen
[email protected]
212-342-4102
Marco B. Zoccali, MD (PRINCIPAL_INVESTIGATOR)
Female Urology of Nashville Research PartnershipNashvilleTennessee37209
Esha Ramjee
Ly Hoang Roberts, MD (PRINCIPAL_INVESTIGATOR)
Houston ColonHoustonTexas77030
Jimena Alcocer-Barrios
[email protected]
713-790-0600
Eric M. Haas, MD (PRINCIPAL_INVESTIGATOR)

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