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Real-World Registry - The Vivally® System

NCT06085846 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Avation Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2043-07-01
Completion
2043-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085846 on ClinicalTrials.gov