Status:
ENROLLING_BY_INVITATION
Real-World Registry - The Vivally® System
Lead Sponsor:
Avation Medical, Inc.
Conditions:
Urinary Incontinence
Urinary Urge Incontinence
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System. Gather feedback from patients on their experience and satisf...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2043
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06085846
Start Date
July 14 2023
End Date
July 1 2043
Last Update
May 29 2024
Active Locations (1)
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1
Avation Medical
Columbus, Ohio, United States, 43201