Safety & Effectiveness of TENS Weight Management Compared to a Sham

NCT05675384 | Completed FDA Device

• 1 other identifier: CD-006
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up

Conditions

Obesity, Mild

Outcome Measures

Primary Outcomes (2)

• A difference in Percent Total Body Weight Loss (%TBWL)

  A difference in Percent Total Body Weight Loss (%TBWL) of greater than 0 (true mean percent of 2%) at 3-months in the Elira System (active) treatment group when compared to the sham (control) group who complete 3-months of treatment

  Three Months

• A responder rate of at least 35% in the active treatment

  A responder rate of at least 35% in the active treatment participants who complete 3-months of treatment, calculated as the percentage achieving at least a 5% TBWL at 3-months

  Three Months

Secondary Outcomes (4)

• Changes in appetite as measured by Appetite Visual Analogue Scale (VAS)

  Three Months

• Changes in BMI

  Three Months

• Changes in eating behaviors as measured by TFEQ scores

  Three Months

• Impact of weight on quality of life (IWQOL-Lite) scores

  Three Months

Study Arms (2)

TENS Active Treatment

EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Management (The Elira System)

Device: TENS Active Treatment

Sham Control Device

SHAM COMPARATOR

Sham TENS unit that provides no actual therapy

Device: Sham Device

Interventions

TENS Active Treatment DEVICE

Using a 7-day/week wearable TENS device controlled by a Smart Phone App combined with moderate intensity lifestyle therapy,

TENS Active Treatment

Sham Device DEVICE

Using the sham (control) device combined with a moderate intensity lifestyle follow-up

Sham Control Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is between 18 - 65 years of age inclusive.
• Participant has a BMI of 25 to \< 35 kg/ m2.
• Participant has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
• Participant is able to use a touch screen handheld smart phone.
• Participant has Wi-Fi internet access for the duration of the study.
• Participant is fluent in English or Spanish and can complete questionnaires.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening and enrollment visit and agree to using birth control to avoid pregnancy during the trial, prior to placement of assigned treatment device.
• Participant agrees to adhere to diet \& exercise recommendations throughout study duration.
• Participant is willing and able to adhere to assigned therapy throughout the study duration.
• Participant has not participated in any clinical trial (except a registry) within the last 30 days.-

You may not qualify if:

• Participant has any known gastrointestinal disorder that in the opinion of the Investigator precludes enrollment into the trial.
• Participant has had a prior bariatric surgical procedure, endoscopic bariatric therapy, or surgery on the stomach.
• Participant has any significant multisystem disease in the opinion of the Investigator.
• Participant is a Type 2 diabetic.
• Participant has a history of significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
• Participant has an existing implanted electrical stimulator (e.g., pacemaker, AICD, cochlear implant).
• For female participants: planned pregnancy within 6 months from study start, active pregnancy, or currently breast feeding.
• Participant has current and/or a history of cancer with the exception of non-melanoma skin cancer or cervical carcinoma in situ \< 3 years before study enrollment.
• Participant has had a weight change of ± 5% of his/her Total Body Weight in the 3 months prior to screening.
• Participant has an uncontrolled psychiatric disorder.
• Participant has a diagnosed neurological disease.
• Participant has a skin disorder affecting the thoracic dermatomes.
• Participant has active/has ever had shingles in the abdominal area.
• Participant has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI.
• Participant 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 or sensitivity to latex, nickel and/or hydrogels.

Sponsors & Collaborators

• Elira, Inc.: lead

Study Sites (6)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

EmVenio

Santa Monica, California, 90404, United States

Location

A New You

Miami, Florida, 33156, United States

Location

Advanced Research for Health Improvement, LLC (ARHI)

Naples, Florida, 34102, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

West County OB/GYN Specialists

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Obesity; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: July 29, 2022
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: July 31, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)