At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).
The goal of this prospective study is to evaluate Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen. The main questions are : * Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. * Safety of the Trim II treatment for lipolysis and abdominal circumference reduction Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Trim II hands-free applicator composed of 4 units applied to the abdominal area, using a single-use belt. Each treatment duration will be 45-60 minutes. Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).
H/K/B Cosmetic Surgery
Huntersville, North Carolina, United States
Bucky Body Center
Philadelphia, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute
Dallas, Texas, United States
Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline.
Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. Success criteria: Statistically significant reduction in abdominal circumference tape measurements at the 3 months follow-up visit compared to baseline
Time frame: 3 months
Safety of the Trim II Treatment for Lipolysis and Abdominal Circumference Reduction.
Number of participants with incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]) will be followed throughout the whole study. Observation, assessment, and recording of potential reactions by the investigator. Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, severity, and causality of reactions will be recorded.
Time frame: 3 months
Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators
Success criteria: Correct identification of baseline and 3-month follow-up visit photographs of the abdomen (treatment) area in at least 70% of treated subjects by two blinded evaluators.
Time frame: 3 months
Change in Abdominal Fat Thickness Measured by Ultrasound Imaging (USI) at the 3 Months Follow-up Visit Comparing to Baseline.
Success criteria: statistically significant change in fat thickness of the abdomen (treatment) area measurements at the 3 months follow-up visit compared to baseline.
Time frame: 3 months
Subject's Satisfaction With Study Treatment at 3 Months Follow-up Visit.
Subject's satisfaction with the therapy results was evaluated through the Subject Satisfaction Questionnaire (5-point scale). The higher the score the better the outcome. 2-Very satisfied, 1-satisfied, 0-indifferent, -1 disappointed, -2- very disappointed
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Refresh Dermatology
Houston, Texas, United States
Time frame: 3 months
Treatment Comfort During the Study Treatment.
Average of comfort post treatment evaluated using the Therapy Comfort Questionnaire. Scored from-2 to +2. The higher the score the better the outcome. Average value is calculated
Time frame: Immediately post each treatment once in 2 weeks for 6 weeks