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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Neurovalens Ltd.
- Enrollment
- 241
- Locations
- 4
- Primary Endpoint
- Percentage Change of Weight From Baseline
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Body mass index BMI ≥ 27 kg/m
- •Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test at screen and also just before each DXA scan. (As DXA involves a small dose of ionizing radiation). They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
- •22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
- •Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
- •Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
- •Agreement not to start smoking tobacco or marijuana
Exclusion Criteria
- •History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
- •History of bariatric surgery, or gastric resection.
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- •History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
- •Use of a non-invasive weight loss device (e.g. Modius)
- •Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
- •Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
- •Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
- •Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
- •Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
Outcomes
Primary Outcomes
Percentage Change of Weight From Baseline
Time Frame: From baseline to 6 months
The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device
Categorical: Proportion of Participants Who Lose 5% Total Body Weight
Time Frame: 6 months
The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control
Secondary Outcomes
- Mean Percent Loss of Baseline Visceral Adipose Tissue(% change in VAT mass at 6 months)
- Percentage Fat Loss(Percentage change from baseline to 6 months)
- Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group(Absolute change at 3 months and 6 months)
- Atherogenic Index(Absolute change from baseline to 6 months)
- Systemic Inflammation(Percentage change from baseline to 6 months)
- Total Energy Intake (kcal)(Change from baseline to 6 months)
- Quality of Life Ratings(Absolute change from baseline to 6 months)