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NCT04124419

Safety and Efficacy of Combined EMS and RF Treatments

Completed NA Results posted Last updated 27 February 2026
What this trial tests

NA trial testing Treatment with Evolve System in Non-invasive Circumference Reduction in 20 participants. Completed in 19 May 2021.

Timeline
19 July 2019
Primary endpoint
19 May 2021
19 May 2021

Quick facts

Lead sponsorInMode MD Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date19 July 2019
Primary completion19 May 2021
Estimated completion19 May 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

InMode MD Ltd.

Who can join

Adults 18 to 65, any sex, with Non-invasive Circumference Reduction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Circumference Reduction Primary · Baseline to 6 months following last treatment session

Change in circumference measured in centimeters from baseline to 6 months following the last treatment session. Circumference was measured using a standard measuring tape. Negative values indicate a reduction in circumference.

GroupValue95% CI
Treatment Arm-0.86-1.46 – 1.5
Change in Abdomen Area Appearance Assessed by Investigator Secondary · 6 month

\- Investigator assessment of the skin appearance comparing pre and post treatment using 0 - 4 -points Likert scale at follow up visits: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference Higher score = better improvement

GroupValue95% CI
Treatment Arm1.36± 0.64
Subject Improvement Assessment Secondary · 6 Months

Improvement assessment will be performed independently by the subject himself using 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference.

GroupValue95% CI
Treatment Arm1.9± 1.23
Subject Satisfaction Assessment Secondary · 6 months

Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. Higher scores indicate greater satisfaction.

GroupValue95% CI
Treatment Arm1.18± 0.385

Sponsor's own description

The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other InMode MD Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04124419.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing