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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06085846
Other study ID # AMOAB2301
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 14, 2023
Est. completion date July 1, 2043

Study information

Verified date May 2024
Source Avation Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


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 Avation Medical Columbus Ohio

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
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