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

NCT03936699 | Completed Results FDA Device

• 1 other identifier: CD-005
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to demonstrate safety and effectiveness of a wearable patch TENS system (Appendix 2) in driving weight loss and appetite suppression when coupled with an integrated weight loss reduction strategy. The study is designed to demonstrate that TENS stimulation sufficient to drive weight loss and appetite suppression is safe and tolerable when compared to standard of care, and that adverse events/adverse device effects are similar to other TENS device use cases.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events

  Treatment Emergent Adverse Events \[Time Frame: 12 weeks\] Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated serious adverse events (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

• Change in Appetite as Measured by a Visual Analogue Scale From Baseline

  Appetite Changes \[Time Frame: 12 weeks\] Percent change in appetite scores at the end of the trial compared to Baseline between Treatment and Control. Subjects are asked to score level of satisfaction, fullness, hunger and ability to eat on a Visual Analogue Scale of 1 to 100 before and after meals with lower scores indicating lower satisfaction, fullness, hunger or ability to eat, respectively. Scores are captured in a diary once a week with 8 time points. The weeks are captured as week 0 through week 12. The time points at each week include: * 30 minutes before breakfast * 30, 60, and 90 minutes after breakfast * Pre-lunch * Midafternoon * 30 minutes before dinner * Bedtime For each of the four appetite suppression variables (satisfaction, fullness, hunger and ability to eat), the 8 time points at week zero will be averaged for the baseline score (baseline), and the 8 time points at week 12 will be averaged for the 3-month score (3month).

  3 months

Secondary Outcomes (2)

• Change in Percent Total Body Weight Loss

  3 months

• Changes in BMI

  3 months

Study Arms (2)

Treatment

EXPERIMENTAL

The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome 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 Radio Frequency (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. Behavioral: Diet \& Exercise Subjects to be instructed on a healthy 1200 calorie diet.

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/ 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.

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 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.

Sponsors & Collaborators

• Elira Therapeutics, Inc.: lead

Study Sites (1)

West County OB/GYN Specialists

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Body Weight Changes; 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

Results Point of Contact

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

samlung@elira.com

513.236.6799

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 29, 2018
• First Posted: May 3, 2019
• Study Start: June 22, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)