Weight Loss Clinical Trial
— ELIRA_2Official title:
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression
NCT number | NCT03936699 |
Other study ID # | CD-005 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2018 |
Est. completion date | May 30, 2019 |
Verified date | December 2021 |
Source | Elira Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 161 |
Est. completion date | May 30, 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Subject is between 18 - 65 years of age inclusive. 2. Subject has a BMI of 25-35 kg/ m2 inclusive. 3. Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule. 4. Subject is able to wear and use a wearable, patch TENS system. 5. Subject is able to use a touch screen hand held smart phone. 6. Subject is fluent in English and can complete questionnaires. 7. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening or enrollment visit, prior to placement of ELIRA device. 8. 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. Exclusion Criteria: 1. Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial. 2. Subject has had a prior bariatric procedure or any previous procedure on the stomach. 3. Subject has any significant multisystem disease in the opinion of the PI. 4. Subject has > 6.5 HbA1c. 5. Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease. 6. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD). 7. Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial period. 8. Subject has current and/or a history of cancer within the past 5 years (not including basal cell carcinoma or cervical carcinoma in situ). 9. Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to screening. 10. Subject has a moderate / severe psychiatric disorder. 11. Subject has a diagnosed neurological disease. 12. Subject has a diagnosed eating disorder. 13. Subject has a skin disorder affecting the thoracic dermatomes. 14. Subject has active or /has ever had shingles in the abdominal area. 15. Subject has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI. 16. Subject is currently enrolled in other potentially confounding research. 17. Subject 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 to latex, nickel and/or hydrogels. 18. Subject has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion. 19. Subject is actively participating or unwilling to discontinue participation in another weight loss program. Subjects may not enroll in paid or unpaid programs that involve in-person or online apps or coaching, beginning new fitness regimens or utilizing meal planning or paid nutritional coaching during the course of the ELIRA study 20. Subject is taking weight loss control medications including but not limited to Over The Counter (OTC) medications, Metformin, and Belviq. (See Appendix 8) 21. Subject is planning any major medical treatments or surgeries that could cause weight loss. 22. Subject is unable to take anti-nausea medications planned for the study. 23. Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking). 24. Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date. 25. History of treatment for or current abuse of drug or alcohol. 26. A score of =10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression. 27. Any subject that the investigator considers inappropriate for the study for medical reasons. 28. Subject has a history of moderate/severe migraines or other severe headache disorders requiring the treatment of Topiramate. 29. Subject is on drug therapy which may alter antral motility or appetite, per PI discretion. |
Country | Name | City | State |
---|---|---|---|
United States | West County OB/GYN Specialists | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Elira Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in Percent Total Body Weight Loss | Percent reduction in total body weight loss (%TBWL), measured as End Weight - Initial Weight, multiplied by 100, at the end of Experimental period compared to Baseline between Treatment and Control. | 3 months | |
Secondary | Changes in BMI | Changes in BMI [ Time Frame: 3 months ] | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Terminated |
NCT03316105 -
Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Active, not recruiting |
NCT04353726 -
Knowledge-based Dietary Weight Management.
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
Completed |
NCT02877004 -
LLLT for Reducing Waste Circumference and Weight
|
N/A | |
Active, not recruiting |
NCT04327141 -
Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
|
N/A | |
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Recruiting |
NCT05942326 -
Sleep Goal-focused Online Access to Lifestyle Support
|
N/A | |
Completed |
NCT00535600 -
Effects of Bariatric Surgery on Insulin
|
||
Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
Active, not recruiting |
NCT04357119 -
Common Limb Length in One-anastomosis Gastric Bypass
|
N/A | |
Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
Completed |
NCT02945410 -
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
|
N/A | |
Completed |
NCT03139760 -
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
|
N/A | |
Completed |
NCT03210207 -
Gastric Plication in Mexican Patients
|
N/A | |
Recruiting |
NCT02559479 -
A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
|
N/A |