Real-World Registry - The Vivally® System
Enrolling by invitation
Conditions studied: Urinary Incontinence, Urinary Urge Incontinence
In brief
This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to: Therapy compliance and stimulation metrics Diary entries provided by patients Various questionnaires Participants have the option to opt out of allowing their data to be part of any publication at any time.
Key facts
- Study ID
- NCT06085846
- Run by
- Avation Medical, Inc.
- People needed
- 5000
- Starts
- 2023-07-14
- Expected to finish
- 2043-07-01
- Last updated by the study team
- 2024-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible for the Real-World Registry Study, Participants must satisfy all of the following criteria:
- Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional
- Have provided informed consent to have their data included in publications associated with this study
You may not qualify if…
- While it is up to the discretion of the clinician to prescribe the Vivally® System for a specific patient, the Vivally® System is contraindicated for use on patients who have the following history or conditions:
- Patients with pacemakers of implanted defibrillators
- Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function
- This product is not intended for intra-cardiac or trans-thoracic use
- Additional contraindications, warnings and precautions are listed in the User Guide.
Where it is running
- Avation Medical — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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