Clinical Trials Logo

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT03299881
Study type Interventional
Source Elira Therapeutics, Inc.
Status Terminated
Phase N/A
Start date September 5, 2017
Completion date April 1, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Active, not recruiting NCT05040971 - Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes Phase 3
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03714646 - Beta Glucan and Acetate Production N/A
Active, not recruiting NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT03255005 - Endomina Controlled Study N/A