NCT03640286

Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

Clinical Investigation Protocol for the Demonstration of Safety and Efficacy of VeSTAL Weight Loss Device in Human Subjects. Randomized Study of VeSTAL in Patients Who Are Overweight

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat. The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).

Detailed description

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program. * Allocation: Randomized * Endpoint classification: Efficacy Study * Intervention Model: Parallel Assignment in 1:1 active to control allocation * The aim of the study is to recruit a total (i.e. across all 4 sites) of 200 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 10% this should generate a minimum of 90 active treatment and 90 control subjects. * Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject) * Data from all sites will be collated at the end of the studies and analysis will be performed on one data set. This protocol governs the activities at both the USA and NI/UK clinical sites.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	VeSTAL	The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.

Timeline

• Start date: 2019-08-23
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2018-08-21
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

4 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study