Real-World Registry - The Vivally® System

Sponsor

Avation Medical, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06085846

Collaborator

(none)

5,000

Enrollment

Location

239.6

Anticipated Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Urinary Urge Incontinence	Device: Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application

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 satisfaction with the Vivally® System therapy

Identify trends in dosing, compliance, and therapy parameters in order to optimize the wearable, Vivally® System neuromodulation therapy for participants

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Real-World Registry - The Vivally® System

Actual Study Start Date :

Jul 14, 2023

Anticipated Primary Completion Date :

Jul 1, 2043

Anticipated Study Completion Date :

Jul 1, 2043

Outcome Measures

Primary Outcome Measures

Real-world Usage [Length of Study, on average 20 years]
Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.

Secondary Outcome Measures

Patient Satisfaction [Length of Study, on average 20 years]
Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.
Prescribing Trends [Length of Study, on average 20 years]
Identify trends in dosing in order to optimize the wearable, Vivally® System neuromodulation therapy for prescribers. Dosing consists of therapy pulse width parameters (μs) and therapy schedule (sessions completed per week).
Patient Compliance [Length of Study, on average 20 years]
Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.