Trial Outcomes & Findings for Safety and Efficacy of Combined EMS and RF Treatments (NCT NCT04124419)
NCT ID: NCT04124419
Last Updated: 2026-02-27
Results Overview
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.
COMPLETED
NA
20 participants
Baseline to 6 months following last treatment session
2026-02-27
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment Arm
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=17 Participants
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
Treatment with Evolve System: EMS and RF Treatment
|
|---|---|
|
Age, Customized
Age
|
38.158 years
STANDARD_DEVIATION 9.63 • n=17 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type I
|
1 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type II
|
5 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type III
|
4 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
5 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type V
|
2 Participants
n=17 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
0 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months following last treatment sessionChange 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.
Outcome measures
| Measure |
Treatment Arm
n=17 Participants
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Change in Circumference Reduction
|
-0.86 centimeters (cm)
Interval -1.46 to 1.5
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Treatment Arm
n=17 Participants
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Change in Abdomen Area Appearance Assessed by Investigator
|
1.36 score (0-4 Likert scale)
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 6 MonthsImprovement 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.
Outcome measures
| Measure |
Treatment Arm
n=17 Participants
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Subject Improvement Assessment
|
1.9 score (0-4 Likert scale)
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: 6 monthsSubject 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.
Outcome measures
| Measure |
Treatment Arm
n=17 Participants
Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.
|
|---|---|
|
Subject Satisfaction Assessment
|
1.18 score on a scale
Standard Deviation 0.385
|
Adverse Events
Treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place