Real-World Registry - The Vivally® System

Urinary Incontinence Clinical Trial

Official title:

Real-World Registry - The Vivally® System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06085846
• Other study ID #: AMOAB2301
• Status: Enrolling by invitation
• Start date: July 14, 2023
• Est. completion date: July 1, 2043

Study information

• Verified date: October 2023
• Source: Avation Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: July 1, 2043
• Est. primary completion date: July 1, 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application
Vivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency.

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Avation Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world Usage	Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.	Length of Study, on average 20 years
Secondary	Patient Satisfaction	Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.	Length of Study, on average 20 years
Secondary	Prescribing Trends	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).	Length of Study, on average 20 years
Secondary	Patient Compliance	Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.	Length of Study, on average 20 years