Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss

NCT03299881 | Terminated Results FDA Device

• 1 other identifier: CD-004
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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. The control group will be asked to follow a 12 calorie diet only. Each group will be followed for 12 weeks. Total body weight loss will be measured as well as appetite changes. Safety data will be collected throughout the study period. Safety and effectiveness will be determined based on differences between the groups.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

  Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).

  12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.

Device: Transcutaneous Nerve Stimulator (TENS); Behavioral: Diet & Exercise

Control

ACTIVE COMPARATOR

Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.

Behavioral: Diet & Exercise

Interventions

Transcutaneous Nerve Stimulator (TENS) DEVICE

The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.

Treatment

Diet & Exercise BEHAVIORAL

Subjects to be instructed on a healthy 1200 calorie diet.

Control; Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elira Therapeutics, Inc.: lead

Study Sites (1)

St. Louis Women's Healthcare Group

St Louis, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Early termination due to technical problems with the device. Insufficient data to produce statistically reliable results.

Results Point of Contact

• Title: Stephanie Amlung, PhD, RN, Vice President, Clinical Affairs
• Organization: Elira Therapeutics, Inc.

samlung@elira.com

513-236-6799

Study Officials

• Shelby Sullivan, MD

  Consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, adaptive parallel arm study

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 3, 2017
• Study Start: September 5, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)