Safety and Efficacy of the SMART Device for Overweight and Obese Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that (1) we will observe at least 40% of the subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared to Week 0 is ≥4% in the Per Protocol population.

Official Title
-----------------
A Prospective, Single Arm, Multicenter Study Evaluating the Safety and Weight Loss Efficacy of the SMART Device + DVD Weight Loss Education for Overweight and Obese Adults

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Device: SMART device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject willing and able to sign an informed consent for the study and has signed the IRB approved Information and Consent form for this study. Subject is age 18 to 49 years inclusive. Subject has a BMI between 27 and 35 kg/m² inclusive. Subject reports weight has been stable (no increase or decrease of 3% or more) in the last 3 months. Subject reports that he/she has had a dental check-up within the last 12 months. Subject reports that he/she is under the care of a dentist or orthodontist that the HCP may contact and provides name and location of the dental professional. Subject able to participate fully in and for the full duration of the study. Subject agrees to sign a behavioral contract describing that they understand the mechanism by which the device reduces food intake, that they will use the device during all meals and eating episodes (including snacks and while consuming sugar-sweetened liquids), that they will properly care for the device and that they will attend all study visits. Subject is fully ambulatory. Subject has normal condition, anatomy and function of the oral cavity as self-reported and confirmed by the trained health care provider. If female, the subject is; a. not pregnant (or lactating), and b. using and will continue to use adequate contraception throughout participation in the study. Subject reports no functional problems when swallowing solids or liquids. Subject lives or works within 25 miles of the study site and has a reliable method of transportation. Exclusion Criteria: Subject has participated in a weight loss program and/or in a formal weight loss program (commercial, licensed counselor-delivered or medically supervised) in the last three months preceding anticipated study entry. Subject reports history of, or current, clinically significant disease, including: cardiovascular, pulmonary, gastrointestinal, urological, dermatological, central or peripheral nervous system, or endocrine disease or condition (other than type 2 diabetes that does not require insulin or sulfonylurea). Subject has a history of bariatric surgery. In the opinion of the Investigator, subject has respiratory, dental, oral, or neurological disease or condition that might interfere with use or safety of the SMART device. Subject has compromised oral health (e.g., decay, infection, abscess, loose or cracked teeth, inflamed oral tissue, receding gums, and periodontal disease). Subject uses antipsychotic medication. If the subject is on a stable dose (3 months or more) of an antidepressant he/she can be enrolled in the study. Subject has type 1 or type 2 diabetes and is taking insulin or sulfonylurea. Subject has history of malignant disease, other than non-melanoma skin cancer diagnosed within the last five years and successfully treated. Subject has known allergy to any component of the SMART device. Subject is a current smoker or user of smokeless tobacco or nicotine gum. Subject has recent history of drug or alcohol abuse (in last 3 years). Subject is known to be HIV positive. Subject has been diagnosed with Sjogren's syndrome or chronic dry mouth Subject has any of the following conditions in the oral cavity that would preclude fitting and wearing the device: oral deformity, upper arch removable partial dentures, inadequate oral anatomy (e.g., 3 or more loose or missing teeth on the upper arch, molars or pre-molars either missing or worn down to within 4 mm above gum line, teeth with excessive convexity or undercuts that will make placement and removal of the device difficult, an oro-nasal fistula secondary to cleft palate, or a large torus palatinus), veneers, temporary crowns or recently placed osteointegrated dental implants, and any fixed orthodontic appliances (e.g., braces). Subject is unable to complete the mold-making process. Subject is currently involved in another clinical trial or intends to participate in one during the study period. Subjects are excluded if they report the following eating patterns that are less likely to be helped by the SMART device; diagnosis of night eating syndrome* (wakened by hunger and desire to eat at night); diagnosis of sleep eating* (unconscious eating while asleep); self-report of consumption of 32 or more ounces of sugar-sweetened beverages per day; self-report of extremely slow eating, such that family members and friends remark on the trait; self-report of a grazing eating pattern, defined as eating or snacking in more than 6 episodes per day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART device<br>Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device | Device: SMART device<br>* Sensor Monitored Alimentary Restriction Therapy (SMART) device<br>* Other names: Sensor Monitored Alimentary Restriction Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0 |  | 16 weeks | 
| Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0 |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage Excess Weight Loss (EWL) |  | 16 weeks | 
| Mean Absolute Weight Loss (kg) |  | 16 weeks | 
| Proportion of Subjects Achieving ≥4% Weight Loss |  | 16 weeks | 
| Proportion of Subjects Achieving ≥12% EWL |  | 16 weeks | 
| Percentage Total Body Loss and Treatment Compliance Correlation | The measured relationship between SMART device usage and total weight loss. | 16 weeks | 
| Device Compliance | Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5). | Week 16 |