Safety & Effectiveness of TENS Weight Management Compared to a Sham
Public ClinicalTrials.gov record NCT05675384. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SAFETY AND EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS)-ASSISTED WEIGHT MANAGEMENT (THE ELIRA SYSTEM) AS COMPARED TO A SHAM DEVICE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up
Study identification
- NCT ID
- NCT05675384
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 395 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 28, 2022
- Primary completion
- Jul 22, 2024
- Completion
- Jul 22, 2024
- Last update posted
- Jul 30, 2024
2022 – 2024
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | — |
| EmVenio | Santa Monica | California | 90404 | — |
| A New You | Miami | Florida | 33156 | — |
| Advanced Research for Health Improvement, LLC (ARHI) | Naples | Florida | 34102 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| West County OB/GYN Specialists | St Louis | Missouri | 63141 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05675384, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05675384 live on ClinicalTrials.gov.