Real-World Registry - The Vivally® System
Launched by AVATION MEDICAL, INC. · Oct 10, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility criteria
- 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.
About Avation Medical, Inc.
Aviation Medical, Inc. is a leading clinical trial sponsor specializing in the development and evaluation of innovative medical solutions tailored for the aviation industry. Committed to enhancing the health and safety of aviation personnel and passengers, the company conducts rigorous clinical trials to assess the efficacy and safety of novel therapies and technologies. With a focus on regulatory compliance and ethical standards, Aviation Medical, Inc. collaborates with healthcare professionals, researchers, and regulatory bodies to advance medical knowledge and improve clinical practices within the aviation sector. Their dedication to quality and integrity positions them as a trusted partner in the pursuit of aviation-related health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
Columbus, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported