Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

UltraShape Power for Abdominal Fat and Circumference Reduction

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: NCT02748928
Recruitment Status : Completed
First Posted : April 22, 2016
Results First Posted : March 7, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Excess Abdominal Fat
Intervention Device: UltraShape Power
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treated and Untreated Abdomen
Hide Arm/Group Description Circumference and fat thickness reduction of abdomen after Ultrashape treatments (three treatments with U-sculpt Power transducer Isppa 660 W/cm^2)
Period Title: Overall Study
Started 62
Completed 62
Not Completed 0
Arm/Group Title Treated and Untreated Abdomen
Hide Arm/Group Description Circumference and fat thickness measurements of abdomen before and after Ultrashape treatments of the same subjects
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
42.5  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
58
  93.5%
Male
4
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
American Indian or Alaska Native
3
   4.8%
Asian
3
   4.8%
Native Hawaiian or Other Pacific Islander
1
   1.6%
Black or African American
3
   4.8%
White
52
  83.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants
62
Fat Thickness  
Mean (Standard Deviation)
Unit of measure:  Millimeter
Number Analyzed 62 participants
31.36  (6.44)
Midline Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 62 participants
92.14  (7.86)
1.Primary Outcome
Title Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Abdomen
Hide Arm/Group Description:
Subjects treated on the abdomen with Ultrashape ultrasound treatments
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: percentage change
-10.5  (11)
2.Secondary Outcome
Title Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Treated Abdomen
Hide Arm/Group Description:
Subjects treated on the abdomen with Ultrashape ultrasound treatments
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: percentage change
Fat thickness change at 4 weeks Number Analyzed 62 participants
-3.2  (8.2)
Fat thickness change at 8 weeks Number Analyzed 61 participants
-4.3  (8.4)
Fat thickness change at 12 weeks Number Analyzed 59 participants
-7.0  (9.3)
3.Secondary Outcome
Title Change in Abdominal Circumference Compared to Baseline
Hide Description Abdominal circumference change post UltraShape Power treatments
Time Frame Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Treated Abdomen
Hide Arm/Group Description:
Subjects treated on the abdomen with Ultrashape ultrasound treatments
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: centimeter
Abdominal circumference change at 4 weeks Number Analyzed 62 participants
-1.03  (2.19)
Abdominal circumference change at 8 weeks Number Analyzed 61 participants
-1.29  (2.64)
Abdominal circumference change at 12 weeks Number Analyzed 59 participants
-1.70  (2.52)
Abdominal circumference change at 16 weeks Number Analyzed 62 participants
-2.26  (2.70)
4.Secondary Outcome
Title Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Treated Abdomen
Hide Arm/Group Description:
Abdomen treated with UltraShape ultrasound treatments
Overall Number of Participants Analyzed 62
Measure Type: Count of Participants
Unit of Measure: Participants
Investigator satisfaction rate at 8 week Number Analyzed 61 participants
44
  72.1%
Investigator satisfaction rate at 12 week Number Analyzed 59 participants
43
  72.9%
Investigator satisfaction rate at 16 week Number Analyzed 62 participants
54
  87.1%
5.Secondary Outcome
Title Number of Participants Reporting Satisfaction With Treatment Outcome
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Treated Abdomen
Hide Arm/Group Description:
Subjects treated on the abdomen with Ultrashape ultrasound treatments
Overall Number of Participants Analyzed 62
Measure Type: Count of Participants
Unit of Measure: Participants
Subject satisfaction rate at 8 week Number Analyzed 61 participants
47
  77.0%
Subject satisfaction rate at 12 week Number Analyzed 59 participants
42
  71.2%
Subject satisfaction rate at 16 week Number Analyzed 62 participants
46
  74.2%
6.Secondary Outcome
Title Pain Scale for Rating Discomfort Associated With Treatment
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Abdomen
Hide Arm/Group Description:
Subjects treated on the abdomen with Ultrashape ultrasound treatments
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: score on a scale
Subject discomfort at first treatment 0.32  (0.91)
Subject discomfort at second treatment 0.25  (0.70)
Subject discomfort at third treatment 0.17  (0.70)
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Abdomen
Hide Arm/Group Description Subjects treated on the abdomen with Ultrashape ultrasound treatments
All-Cause Mortality
Treated Abdomen
Affected / at Risk (%)
Total   0/62 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treated Abdomen
Affected / at Risk (%) # Events
Total   0/62 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treated Abdomen
Affected / at Risk (%) # Events
Total   11/62 (17.74%)    
Skin and subcutaneous tissue disorders   
Welts  [1]  9/62 (14.52%)  9
Pruitis / itching  [2]  1/62 (1.61%)  1
Blanching  [3]  1/62 (1.61%)  1
Indicates events were collected by systematic assessment
[1]
Small mild welts
[2]
Itching following treatment
[3]
Mild blanching
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Affairs
Organization: Syneron Medical
Phone: +972-73-2442347
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02748928     History of Changes
Other Study ID Numbers: DHF21621
First Submitted: April 20, 2016
First Posted: April 22, 2016
Results First Submitted: February 12, 2019
Results First Posted: March 7, 2019
Last Update Posted: March 19, 2019