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Obesity, MildNCT05675384

Safety & Effectiveness of TENS Weight Management Compared to a Sham

A study testing TENS Active Treatment in people with Obesity, Mild, run by Elira, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Mild
What is being tested?
TENS Active Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
395 participants
Where
6 sitesUnited States
Study dates
29 Jul 2022to 23 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.-

Who cannot join

  • 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).
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  • 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.
  • Participant has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion.
  • Participant is actively participating or unwilling to discontinue participation in another weight loss program. (Participants may not enroll in paid or unpaid programs that involve inperson or online coaching during the course of the Elira study.)
  • Participant has a history of eating disorders (Bulimia, Binge Eating, Night Eating Syndrome, Compulsive Overeating) and/or screens positive for Binge Eating as measured by the Binge Eating Score (BES) Questionnaire.
  • Participant has taken weight loss medications including but not limited to OTC medications or any other medication known to cause weight loss or weight gain within the 2 months prior to enrollment.
  • Participant is planning any major medical treatments or surgeries that could cause weight loss during the study.
  • Participant works night shift or rotating night shifts that impact scheduled daylight mealtimes.
  • 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 or higher on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression.
  • Any participant that the Investigator considers inappropriate for the study for medical reasons.
  • Participant is taking Topiramate, Adderall, or Ritalin within the 6 months prior to enrollment.
  • Participant is on drug therapy which may alter antral motility or appetite, per Investigator discretion within the 2 months prior to enrollment.
  • History of cirrhosis or pancreatitis.
  • History of COPD or other pulmonary disease that restricts exercise tolerance.
  • Immunocompromised due to medications or disease or HIV positive.
  • History of severe Covid-19 symptoms requiring hospitalization or history of Covid-19 infection with unresolved symptoms.
  • TSH levels > 10mU/L or < 0.1 mU/L.
  • Prior participation in an Elira sponsored study.
  • A current member of the participant's household has been randomized into the Elira 3 study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • A New You

    Miami, Florida, 33156

  • Advanced Research for Health Improvement, LLC (ARHI)

    Naples, Florida, 34102

  • EmVenio

    Santa Monica, California, 90404

  • Honor Health

    Scottsdale, Arizona, 85258

  • Washington University

    St Louis, Missouri, 63110

  • West County OB/GYN Specialists

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: SAFETY AND EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS)-ASSISTED WEIGHT MANAGEMENT (THE ELIRA SYSTEM) AS COMPARED TO A SHAM DEVICE

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

Read the detailed description

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. The objective is to demonstrate the effectiveness of the Elira System combined with a moderate intensity lifestyle therapy program compared to a sham device combined with a moderate intensity lifestyle therapy program control group at 3-months on weight management for participants who are overweight and/or with Class 1 obesity.

Conditions
Obesity, Mild
Being tested
TENS Active Treatment, Sham Device
Medical subject headings
Obesity, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENS Active TreatmentDevice

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

  • Sham DeviceDevice

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

Study groups in NCT05675384
Study groupRoleWhat they receive
TENS Active TreatmentExperimentalTranscutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Management (The Elira System)
Receives: Device: TENS Active Treatment
Sham Control DeviceSham comparatorSham TENS unit that provides no actual therapy
Receives: Device: Sham Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Three Months

  2. 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

    Measured: Three Months

Secondary outcomes (4)

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

    Changes in appetite as measured by Appetite Visual Analogue Scale (VAS) from Baseline to 3-months in the active treatment group compared to the sham control group

    Measured: Three Months

  2. Changes in BMI

    Changes in BMI from Baseline to 3-months in the active treatment group compared to the sham control group

    Measured: Three Months

  3. Changes in eating behaviors as measured by TFEQ scores

    Changes in eating behaviors as measured by TFEQ scores from Baseline to 3-months in the active treatment group compared to the sham control group

    Measured: Three Months

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

    Impact of weight on quality of life (IWQOL-Lite) scores from Baseline to 3-months in in the active treatment group compared to the sham control group

    Measured: Three Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start29 Jul 2022
  3. Primary completion23 Jul 2024
  4. Study completion23 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675384
Sponsor's protocol ID
CD-006
Status last verified
Dec 2022
First submitted
29 Dec 2022
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TENS Active Treatment in people with Obesity, Mild, run by Elira, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A difference in Percent Total Body Weight Loss (%TBWL) (time frame: Three Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05675384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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