NCT02748928

UltraShape Power for Abdominal Fat and Circumference Reduction

Completed NA Results posted Last updated 19 March 2019

What this trial tests

NA trial testing UltraShape Power in Excess Abdominal Fat in 62 participants. Completed in 23 April 2018.

Timeline

8 June 2016

Primary endpoint
15 February 2017

23 April 2018

Quick facts

Lead sponsor	Syneron Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	8 June 2016
Primary completion	15 February 2017
Estimated completion	23 April 2018
Sites	8 locations across United States

Drugs / interventions tested

• UltraShape Power

Conditions studied

• Excess Abdominal Fat — all drugs for Excess Abdominal Fat →

Sponsor

Syneron Medical

Who can join

Adults 18 to 60, any sex, with Excess Abdominal Fat. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound Primary · 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

Group	Value	95% CI
Treated Abdomen	-10.5	± 11

Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound Secondary · 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

Fat thickness change at 4 weeks

Group	Value	95% CI
Treated Abdomen	-3.2	± 8.2

Fat thickness change at 8 weeks

Group	Value	95% CI
Treated Abdomen	-4.3	± 8.4

Fat thickness change at 12 weeks

Group	Value	95% CI
Treated Abdomen	-7.0	± 9.3

Change in Abdominal Circumference Compared to Baseline Secondary · Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)

Abdominal circumference change post UltraShape Power treatments

Abdominal circumference change at 4 weeks

Group	Value	95% CI
Treated Abdomen	-1.03	± 2.19

Abdominal circumference change at 8 weeks

Group	Value	95% CI
Treated Abdomen	-1.29	± 2.64

Abdominal circumference change at 12 weeks

Group	Value	95% CI
Treated Abdomen	-1.70	± 2.52

Abdominal circumference change at 16 weeks

Group	Value	95% CI
Treated Abdomen	-2.26	± 2.70

Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome Secondary · 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.

Investigator satisfaction rate at 8 week

Group	Value	95% CI
Treated Abdomen	44

Investigator satisfaction rate at 12 week

Group	Value	95% CI
Treated Abdomen	43

Investigator satisfaction rate at 16 week

Group	Value	95% CI
Treated Abdomen	54

Number of Participants Reporting Satisfaction With Treatment Outcome Secondary · 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.

Subject satisfaction rate at 8 week

Group	Value	95% CI
Treated Abdomen	47

Subject satisfaction rate at 12 week

Group	Value	95% CI
Treated Abdomen	42

Subject satisfaction rate at 16 week

Group	Value	95% CI
Treated Abdomen	46

Pain Scale for Rating Discomfort Associated With Treatment Secondary · 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.

Subject discomfort at first treatment

Group	Value	95% CI
Treated Abdomen	0.32	± 0.91

Subject discomfort at second treatment

Group	Value	95% CI
Treated Abdomen	0.25	± 0.70

Subject discomfort at third treatment

Group	Value	95% CI
Treated Abdomen	0.17	± 0.70

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treated Abdomen

Serious: 0/62 (0%)

Deaths: 0/62

Other adverse events (3 terms — click to expand)

Reaction	System	Treated Abdomen
Welts	Skin and subcutaneous tissue disorders	—
Pruitis / itching	Skin and subcutaneous tissue disorders	—
Blanching	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT02748928 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.