ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression

Inclusion Criteria

• Subject is between 18 - 65 years of age inclusive.
• Subject has a BMI of 25-35 kg/ m2 inclusive.
• Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
• Subject is able to wear and use a wearable, patch TENS system.
• Subject is able to use a touch screen hand held smart phone.
• Subject is fluent in English and can complete questionnaires.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening or enrollment visit, prior to placement of ELIRA device.
• Subject is male or non-pregnant, non-lactating female, who agrees to use effective contraceptive methods throughout the length of the trial based on PI approval.

Exclusion Criteria

• Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.
• Subject has had a prior bariatric procedure or any previous procedure on the stomach.
• Subject has any significant multisystem disease in the opinion of the PI.
• Subject has > 6.5 HbA1c.
• Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
• Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
• Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
• Subject has current and/or a history of cancer within the past 5 years (not including basal cell carcinoma or cervical carcinoma in situ).
• Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to screening.
• Subject has a moderate / severe psychiatric disorder.
• Subject has a diagnosed neurological disease.
• Subject has a diagnosed eating disorder.
• Subject has a skin disorder affecting the thoracic dermatomes.
• Subject has active or /has ever had shingles in the abdominal area.
• Subject has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI.
• Subject is currently enrolled in other potentially confounding research.
• Subject has known allergic reaction to materials in the TENS electrodes and/or is otherwise unable to tolerate stimulation with the wearable TENS system. This includes known allergies to latex, nickel and/or hydrogels.
• Subject has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion.
• Subject is actively participating or unwilling to discontinue participation in another weight loss program. Subjects may not enroll in paid or unpaid programs that involve in-person or online apps or coaching, beginning new fitness regimens or utilizing meal planning or paid nutritional coaching during the course of the ELIRA study
• Subject is taking weight loss control medications including but not limited to Over The Counter (OTC) medications, Metformin, and Belviq. (See Appendix 8)
• Subject is planning any major medical treatments or surgeries that could cause weight loss.
• Subject is unable to take anti-nausea medications planned for the study.
• Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking).
• Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date.
• History of treatment for or current abuse of drug or alcohol.
• A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression.
• Any subject that the investigator considers inappropriate for the study for medical reasons.
• Subject has a history of moderate/severe migraines or other severe headache disorders requiring the treatment of Topiramate.
• Subject is on drug therapy which may alter antral motility or appetite, per PI discretion.