Trial Outcomes & Findings for UltraShape Power for Abdominal Fat and Circumference Reduction (NCT NCT02748928)
NCT ID: NCT02748928
Last Updated: 2019-03-19
Results Overview
Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline
COMPLETED
NA
62 participants
Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
2019-03-19
Participant Flow
Participant milestones
| Measure |
Treated and Untreated Abdomen
Circumference and fat thickness reduction of abdomen after Ultrashape treatments (three treatments with U-sculpt Power transducer Isppa 660 W/cm\^2)
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UltraShape Power for Abdominal Fat and Circumference Reduction
Baseline characteristics by cohort
| Measure |
Treated and Untreated Abdomen
n=62 Participants
Circumference and fat thickness measurements of abdomen before and after Ultrashape treatments of the same subjects
|
|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
|
Fat Thickness
|
31.36 millimeter
STANDARD_DEVIATION 6.44 • n=5 Participants
|
|
Midline Circumference
|
92.14 centimeter
STANDARD_DEVIATION 7.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
|
-10.5 percentage change
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 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)
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
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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)
Abdominal circumference change post UltraShape Power treatments
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change at 4 weeks
|
-1.03 centimeter
Standard Deviation 2.19
|
|
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change at 8 weeks
|
-1.29 centimeter
Standard Deviation 2.64
|
|
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change at 12 weeks
|
-1.70 centimeter
Standard Deviation 2.52
|
|
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change at 16 weeks
|
-2.26 centimeter
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Investigator satisfaction rate at 8 week
|
44 Participants
|
|
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Investigator satisfaction rate at 12 week
|
43 Participants
|
|
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Investigator satisfaction rate at 16 week
|
54 Participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Number of Participants Reporting Satisfaction With Treatment Outcome
Subject satisfaction rate at 8 week
|
47 Participants
|
|
Number of Participants Reporting Satisfaction With Treatment Outcome
Subject satisfaction rate at 12 week
|
42 Participants
|
|
Number of Participants Reporting Satisfaction With Treatment Outcome
Subject satisfaction rate at 16 week
|
46 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treated Abdomen
n=62 Participants
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Pain Scale for Rating Discomfort Associated With Treatment
Subject discomfort at first treatment
|
0.32 score on a scale
Standard Deviation 0.91
|
|
Pain Scale for Rating Discomfort Associated With Treatment
Subject discomfort at second treatment
|
0.25 score on a scale
Standard Deviation 0.70
|
|
Pain Scale for Rating Discomfort Associated With Treatment
Subject discomfort at third treatment
|
0.17 score on a scale
Standard Deviation 0.70
|
Adverse Events
Treated Abdomen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treated Abdomen
n=62 participants at risk
Subjects treated on the abdomen with Ultrashape ultrasound treatments
|
|---|---|
|
Skin and subcutaneous tissue disorders
Welts
|
14.5%
9/62 • Number of events 9 • Subjects were assessed and followed up for adverse events at each treatment (3 treatments at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the Ultrashape Power treatment
|
|
Skin and subcutaneous tissue disorders
Pruitis / itching
|
1.6%
1/62 • Number of events 1 • Subjects were assessed and followed up for adverse events at each treatment (3 treatments at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the Ultrashape Power treatment
|
|
Skin and subcutaneous tissue disorders
Blanching
|
1.6%
1/62 • Number of events 1 • Subjects were assessed and followed up for adverse events at each treatment (3 treatments at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the Ultrashape Power treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place