Trials / Not Yet Recruiting
Not Yet RecruitingNCT07335484
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Axonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Detailed description
The trial system is used to determine if patients are responsive to sacral neuromodulation (SNM) prior to receiving the Axonics implantable neurostimulator (INS) which is approved for the treatment of OAB and FI. This study is evaluating the feasibility and safety of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Conditions
- Urinary Urge Incontinence (UUI)
- Urinary Frequency (UF)
- Fecal Incontinence (FI)
- Overactive Bladder (OAB)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Axonics External Trial System (ETS) | A temporary electrode wire is passed through the S3 foramen with or without fluoroscopic guidance. The wire is then connected to an external pulse generator (EPG) and is worn for a trial period ranging from 3-7 days. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
- First posted
- 2026-01-13
- Last updated
- 2026-04-15
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07335484. Inclusion in this directory is not an endorsement.