Excess Abdominal Fat
Conditions
Brief summary
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.
Detailed description
Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment). Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
Interventions
DEVICEUltraShape Power
Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
A subject is eligible to participate in the study if he/she meets all the following inclusion criteria: 1. Signed informed consent to participate in the study. 2. Female and male subjects, 18 and 60 years of age at the time of enrollment 3. Fitzpatrick Skin Type I to VI. 4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper). 5. Body mass index (BMI): BMI between 22 to 30 (normal to overweight, but not obese). 6. If female, not pregnant or lactating, must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e. oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence). 7. In addition, negative urine pregnancy test as tested before each treatment and at the last follow-up visit for women with child-bearing potential (e.g. not menopause). 8. General good health confirmed by medical history and skin examination of the treated area. 9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions. 10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study. 11. Willing to have photographs and images taken of the treated areas to be used, de-identified in evaluations, publications and presentations.
Exclusion criteria
A subject is not eligible for participation in this study if he or she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | Baseline and 16 weeks (4 weeks treatment + 12 week follow up) | Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | Baseline and at 4, 8, and 12 weeks (from baseline visit) | Abdominal fat thickness change as measured by ultrasound post UltraShape Power treatments at 4-week, 8-week and 12-week (from baseline visit) versus baseline |
| Change in Abdominal Circumference Compared to Baseline | Baseline and at 4, 8, 12 and 16 weeks (from baseline visit) | Abdominal circumference change post UltraShape Power treatments |
| Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome | 8, 12 and 16 weeks (from baseline visit) | Satisfaction assessment will be performed independently by the investigator using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of Investigators who were satisfied or very satisfied (i.e., reported a 2 or 3) with Participant Treatment Outcome, as assessed by the questionnaire. |
| Number of Participants Reporting Satisfaction With Treatment Outcome | 8, 12 and 16 weeks (from baseline visit) | Satisfaction assessment will be performed independently by the subjects using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of participants who were satisfied or very satisfied (i.e., reported a 2 or 3) with Treatment Outcome, as assessed by the questionnaire. |
| Pain Scale for Rating Discomfort Associated With Treatment | Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment) | Comfort assessment will be performed independently by the subjects using a numerical scale (0-no discomfort to 10-Worst possible discomfort). The subjects will answer this questionnaire after each of the three treatments. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated and Untreated Abdomen Circumference and fat thickness measurements of abdomen before and after Ultrashape treatments of the same subjects | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Treated and Untreated Abdomen |
|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 10.3 |
| Fat Thickness | 31.36 millimeter STANDARD_DEVIATION 6.44 |
| Midline Circumference | 92.14 centimeter STANDARD_DEVIATION 7.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 11 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline
Time frame: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Abdomen | Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | -10.5 percentage change | Standard Deviation 11 |
Secondary
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change post UltraShape Power treatments
Time frame: Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
Population: One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Abdomen | Change in Abdominal Circumference Compared to Baseline | Abdominal circumference change at 4 weeks | -1.03 centimeter | Standard Deviation 2.19 |
| Treated Abdomen | Change in Abdominal Circumference Compared to Baseline | Abdominal circumference change at 8 weeks | -1.29 centimeter | Standard Deviation 2.64 |
| Treated Abdomen | Change in Abdominal Circumference Compared to Baseline | Abdominal circumference change at 12 weeks | -1.70 centimeter | Standard Deviation 2.52 |
| Treated Abdomen | Change in Abdominal Circumference Compared to Baseline | Abdominal circumference change at 16 weeks | -2.26 centimeter | Standard Deviation 2.7 |
Secondary
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change as measured by ultrasound post UltraShape Power treatments at 4-week, 8-week and 12-week (from baseline visit) versus baseline
Time frame: Baseline and at 4, 8, and 12 weeks (from baseline visit)
Population: One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Abdomen | Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | Fat thickness change at 8 weeks | -4.3 percentage change | Standard Deviation 8.4 |
| Treated Abdomen | Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | Fat thickness change at 4 weeks | -3.2 percentage change | Standard Deviation 8.2 |
| Treated Abdomen | Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound | Fat thickness change at 12 weeks | -7.0 percentage change | Standard Deviation 9.3 |
Secondary
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Satisfaction assessment will be performed independently by the investigator using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of Investigators who were satisfied or very satisfied (i.e., reported a 2 or 3) with Participant Treatment Outcome, as assessed by the questionnaire.
Time frame: 8, 12 and 16 weeks (from baseline visit)
Population: One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Abdomen | Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome | Investigator satisfaction rate at 8 week | 44 Participants |
| Treated Abdomen | Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome | Investigator satisfaction rate at 12 week | 43 Participants |
| Treated Abdomen | Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome | Investigator satisfaction rate at 16 week | 54 Participants |
Secondary
Number of Participants Reporting Satisfaction With Treatment Outcome
Satisfaction assessment will be performed independently by the subjects using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of participants who were satisfied or very satisfied (i.e., reported a 2 or 3) with Treatment Outcome, as assessed by the questionnaire.
Time frame: 8, 12 and 16 weeks (from baseline visit)
Population: One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Abdomen | Number of Participants Reporting Satisfaction With Treatment Outcome | Subject satisfaction rate at 8 week | 47 Participants |
| Treated Abdomen | Number of Participants Reporting Satisfaction With Treatment Outcome | Subject satisfaction rate at 12 week | 42 Participants |
| Treated Abdomen | Number of Participants Reporting Satisfaction With Treatment Outcome | Subject satisfaction rate at 16 week | 46 Participants |
Secondary
Pain Scale for Rating Discomfort Associated With Treatment
Comfort assessment will be performed independently by the subjects using a numerical scale (0-no discomfort to 10-Worst possible discomfort). The subjects will answer this questionnaire after each of the three treatments.
Time frame: Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Abdomen | Pain Scale for Rating Discomfort Associated With Treatment | Subject discomfort at first treatment | 0.32 score on a scale | Standard Deviation 0.91 |
| Treated Abdomen | Pain Scale for Rating Discomfort Associated With Treatment | Subject discomfort at second treatment | 0.25 score on a scale | Standard Deviation 0.7 |
| Treated Abdomen | Pain Scale for Rating Discomfort Associated With Treatment | Subject discomfort at third treatment | 0.17 score on a scale | Standard Deviation 0.7 |