Status:
TERMINATED
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
Lead Sponsor:
Elira Therapeutics, Inc.
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is a randomized, adaptive, parallel arm study. The treatment group will receive the Elira wearable patch system and provided instructions for use and advised to follow a 1200 calorie diet. ...
Detailed Description
This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled subjects (25 per arm) are assessed for dose response and progression to achievement of primary and secondary...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject is between 18 - 65 years of age inclusive.
- Subject has a BMI of 25-35 kg/ m\^2 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 patient questionnaires.
- Subject can comply with a 1200 calorie the recommended diet for the duration of the study.
- 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.
- Females of childbearing potential must have a negative urine pregnancy test at enrollment visit, prior to placement of ELIRA device.
- 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.
- 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.
- Subject has a history of any malignancy in the last 2 years.
- Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to enrollment.
- 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 abdominal surgery or other scars which may interfere with 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 electrodes and/or is otherwise unable to tolerate stimulation with the wearable TENS system.
- Subject is actively participating or unwilling to discontinue participation in another weight loss program.
- Subject is taking weight loss control medications including but not limited to OTC medications, Metformin, and Belviq.
- 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 drugs 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 migraine and/or is taking Topiramate for severe headache disorders.
- Subject is on hormonal or other drug therapy which may alter antral motility or appetite, per physician discretion.
Exclusion
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03299881
Start Date
September 5 2017
End Date
April 1 2018
Last Update
November 10 2021
Active Locations (1)
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1
St. Louis Women's Healthcare Group
St Louis, Missouri, United States, 63017