NCT06085846

Real-World Registry - The Vivally® System

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Avation Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Urinary Incontinence
• Urinary Urge Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-14
• Primary completion: 2043-07-01
• Completion: 2043-07-01
• First posted: 2023-10-17
• Last updated: 2024-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study