Safety and Efficacy of Combined EMS and RF Treatments
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04124419|
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : August 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-invasive Circumference Reduction||Device: Treatment with Evolve System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening|
|Actual Study Start Date :||July 19, 2019|
|Actual Primary Completion Date :||May 19, 2021|
|Actual Study Completion Date :||May 19, 2021|
Experimental: 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.
Device: Treatment with Evolve System
EMS and RF Treatment
- Change in circumference reduction [ Time Frame: 1 month, 3 month, 6 months ]statistical difference in circumference reduction between Control (baseline measurement) and three points of follow-up measurement: 4 weeks (1Month) 12 weeks (3Month) and 24 weeks (6 months) following the last Tx session.
- Change in skin appearance [ Time Frame: 1 month, 3 month, 6 months ]
Improvement in skin appearance comparing pre and at 1, 3 months and 6 months post last treatment photographs (as assessed by blinded investigators):
Success is defined by correct identification of the pre and post-treatment photos as demonstrated in at least 70% or greater of patients completed the treatment at 1 month, 3 months, and 6 months post-treatment.
- Change in abdomen area appearance assessed by 3D Photographic analysis [ Time Frame: 1 month, 3 month, 6 months ]3D Photographic analysis will be conducted using QuantifiCare System at follow up visits and compared to the baseline.
- Change in abdomen area appearance assessed by Investigator [ Time Frame: 1 month, 3 month, 6 months ]- 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
- Subject Improvement assessment [ Time Frame: 1 Month, 3 Months, 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.
- Subject satisfaction assessment [ Time Frame: 1 month, 3 months, 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.
- Subject assessment of comfort [ Time Frame: 1 month, 3 months, 6 months ]
Subject assessment of comfort will be filled out by subjects using a 5-point Likert scale, as follows:
+2 = Very comfortable; +1 = Comfortable; 0 = Indifferent; -1 = uncomfortable; -2 = Pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124419
|United States, Nevada|
|Avance Plastic Surgery Institute|
|Reno, Nevada, United States, 89511|
|United States, New York|
|New York, New York, United States, 10019|