OverweightNCT03299881
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
A study testing Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise in people with Overweight and Obesity, run by Elira Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Women's Healthcare Group
St Louis, Missouri, 63017
About this study
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.
Read the 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 endpoints. Enrollment will be up to 300 subjects at 4 US centers.
After signing informed consent, subjects will be screened during a one week screening/baseline period to determine if they meet the inclusion criteria and exhibit none of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. If eligible, subjects will be randomized to treatment or control groups. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office. Both groups will receive an electronic scale and instructions on 1200 calorie diet as well as diary completion requirements to be completed throughout the study. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.
- Conditions
- Overweight, Obesity
- Being tested
- Transcutaneous Nerve Stimulator (TENS), Diet & Exercise
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Diet & ExerciseBehavioural
Subjects to be instructed on a healthy 1200 calorie diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Diet & Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start5 Sep 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Why it stopped: Early termination due to technical problems with the device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized, adaptive parallel arm study
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shelby Sullivan, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299881
- Sponsor's protocol ID
- CD-004
- Status last verified
- Jan 2021
- First submitted
- 25 Sep 2017
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
- ClinicalTrials.gov ID
- NCT03299881
- Acronym / sponsor ID
- CD-004
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to technical problems with the device.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Elira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 endpoints. Enrollment will be up to 300 subjects at 4 US centers.
After signing informed consent, subjects will be screened during a one week screening/baseline period to determine if they meet the inclusion criteria and exhibit none of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. If eligible, subjects will be randomized to treatment or control groups. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office. Both groups will receive an electronic scale and instructions on 1200 calorie diet as well as diary completion requirements to be completed throughout the study. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, adaptive parallel arm study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcutaneous Nerve Stimulator (TENS), Behavioral: Diet & ExerciseThe 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. |
| Control | Active comparator | Behavioral: Diet & ExerciseOpen label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Nerve Stimulator (TENS)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. | Device | Treatment |
| Diet & ExerciseSubjects to be instructed on a healthy 1200 calorie diet. | Behavioural | Control, Treatment |
Primary outcome
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 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelby Sullivan, MD principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise in people with Overweight and Obesity, run by Elira Therapeutics, Inc. at 1 site 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 9 inclusion and 26 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: stopped early, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Emergent Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.