At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating VeSTAL for Obesity. Completed, enrolled 241 participants across 4 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
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.