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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
~115 spots leftby Jun 2025
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