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Behavioural Intervention

TENS Active Treatment for Obesity

N/A
Recruiting
Research Sponsored by Elira, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months
Awards & highlights

Study Summary

This trial tests a device combined with lifestyle changes to treat overweight/obese people. It compares the device to a sham device to see if it's safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A difference in Percent Total Body Weight Loss (%TBWL)
A responder rate of at least 35% in the active treatment
Secondary outcome measures
Changes in BMI
Changes in appetite as measured by Appetite Visual Analogue Scale (VAS)
Changes in eating behaviors as measured by TFEQ scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TENS Active TreatmentExperimental Treatment1 Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Management (The Elira System)
Group II: Sham Control DevicePlacebo Group1 Intervention
Sham TENS unit that provides no actual therapy

Find a Location

Who is running the clinical trial?

Elira, Inc.Lead Sponsor

Media Library

Elira System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05675384 — N/A
Obesity Research Study Groups: Sham Control Device, TENS Active Treatment
Obesity Clinical Trial 2023: Elira System Highlights & Side Effects. Trial Name: NCT05675384 — N/A
Elira System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675384 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this testing protocol have any age restrictions?

"This research study is seeking individuals aged 18 and above, with a maximum age of 65 for eligibility."

Answered by AI

Are there any available opportunities to participate in this study at present?

"According to clinicaltrials.gov, this particular medical investigation is actively seeking participants who meet its inclusion criteria; it was initially advertised on July 29th 2022 and recently updated on January 6th 2023."

Answered by AI

What is the participant capacity of this clinical trial?

"In this trial, 325 qualified participants are sought. There is a variety of medical sites that eligible patients can choose from, such as EmVenio in Santa Monica and A New You in Miami."

Answered by AI

How geographically dispersed is the execution of this medical experiment?

"This trial is administered at various locations across the country, such as EmVenio in Santa Monica and A New You in Miami. Additionally, Advanced Research for Health Improvement (ARHI) based in Naples and three other sites are taking part."

Answered by AI

What is the primary intent of this research endeavor?

"The primary assessment of this experiment, which will span the period of 3 months, is to quantify a response rate over 35% in active treatment. Secondary measurements include comparison between baseline and 3-month BMI values from both the control and experimental arms; changes in dietary habits as judged by TFEQ scores; and alterations in quality of life (IWQOL-Lite) scores."

Answered by AI

Are there particular criteria for individuals to qualify for participation in this research?

"This clinical trial is seeking 325 adults aged between 18 and 65 with mild obesity. In order to be eligible, patients must have a BMI of 25 to 35 kg/ m2; proficiency in either English or Spanish; access to Wi-Fi internet for the duration of the study; ability to use touch screen handheld smart phones; willingness and capacity to adhere to assigned therapy throughout the study period, diet & exercise recommendations, as well as exclusion criteria from other trials within 30 days before enrollment. For female participants of childbearing potential (FOCBP), they must also present negative urine pregnancy tests upon screening and enrolling visits while agreeing on contraceptive measures"

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Washington University
West County OB/GYN Specialists
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~122 spots leftby Mar 2025