We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

VelaShape III & UltraShape Power for Thigh 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: NCT03430245
Recruitment Status : Completed
First Posted : February 12, 2018
Results First Posted : December 26, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Circumference Reduction
Interventions Device: VelaShape III
Device: UltraShape Power
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description

Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.

The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.

The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.

Period Title: Overall Study
Started 16
Completed 9 [1]
Not Completed 7
Reason Not Completed
Withdrawal by Subject             6
Lost to Follow-up             1
[1]
6 subjects withdrew from study due to lengthy treatment. Treatment protocol amended.
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description

Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.

The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.

The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.

Overall Number of Baseline Participants 16
Overall Number of Units Analyzed
Type of Units Analyzed: Number of thighs
32
Hide Baseline Analysis Population Description
Subjects treated with VelaShape III and UltraShape Power
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
46.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
16
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
4
  25.0%
Not Hispanic or Latino
12
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
16
 100.0%
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 16 participants
16
Mean thigh circumference   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 32 Number of thighs
62.1  (6.0)
[1]
Measure Description: Collected using a measuring tape at thigh midline
1.Primary Outcome
Title Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
Hide Description Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Time Frame At 12 weeks after the third treatment (week 16) for each subject
Hide Outcome Measure Data
Hide Analysis Population Description
6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description:
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
Overall Number of Participants Analyzed 9
Overall Number of Units Analyzed
Type of Units Analyzed: Number of thighs
18
Mean (Standard Deviation)
Unit of Measure: centimeter
-2.8  (1.8)
2.Secondary Outcome
Title Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Hide Description

The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline.

The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively).

Negative change represent reduction in thigh circumference.

Time Frame At 2, 4, 8 and 12 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description:
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Thighs
20
Mean (Standard Deviation)
Unit of Measure: centimeter
Circumference change at the second treatment Number Analyzed 20 Number of Thighs
-0.4  (0.6)
Circumference change at the third treatment Number Analyzed 20 Number of Thighs
-0.8  (0.7)
Circumference change at 8 weeks after baseline Number Analyzed 18 Number of Thighs [1] 
-1.8  (0.8)
Circumference change at 12 weeks after baseline Number Analyzed 18 Number of Thighs [1] 
-2.2  (1.6)
[1]
9 participants
3.Secondary Outcome
Title Investigator Satisfaction
Hide Description Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)
Time Frame At 4, 8 and 12 weeks follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description:
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Investigator satisfaction at 4 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
0
   0.0%
(1) Satisfied
5
  55.6%
(2) Very satisfied
4
  44.4%
Investigator satisfaction at 8 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
0
   0.0%
(1) Satisfied
4
  44.4%
(2) Very satisfied
5
  55.6%
Investigator satisfaction at 12 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
0
   0.0%
(1) Satisfied
2
  22.2%
(2) Very satisfied
7
  77.8%
4.Secondary Outcome
Title Subject Satisfaction
Hide Description Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).
Time Frame At 4, 8 and 12 week follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description:
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Subject satisfaction at 4 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
0
   0.0%
(1) Satisfied
3
  33.3%
(2) Very satisfied
6
  66.7%
Subject satisfaction at 8 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
1
  11.1%
(1) Satisfied
3
  33.3%
(2) Very satisfied
5
  55.6%
Subject satisfaction at 12 week follow-up (-2) Very unsatisfied
0
   0.0%
(-1) Unsatisfied
0
   0.0%
(0) No Opinion
0
   0.0%
(1) Satisfied
2
  22.2%
(2) Very satisfied
7
  77.8%
Time Frame The period of time over which adverse event data were collected is from treatment visit until 12 weeks follow-up (16 weeks post baseline) treatment
Adverse Event Reporting Description The number and severity of adverse events following each treatment, with combined Velashape III and Ultrashape Power for the thighs, were evaluated at each of the three biweekly visits and at the 4, 8 and 12 weeks following the treatment.
 
Arm/Group Title VelaShape III & UltraShape Power
Hide Arm/Group Description Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
All-Cause Mortality
VelaShape III & UltraShape Power
Affected / at Risk (%)
Total   0/16 (0.00%)    
Hide Serious Adverse Events
VelaShape III & UltraShape Power
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VelaShape III & UltraShape Power
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Skin and subcutaneous tissue disorders   
Blistering  [1]  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
Patient developed 2 blisters on left thigh at the day after the second treatment. Subject advised to keep area clean & covered and to temporarily discontinue treatments. The blisters recovered without intervention.
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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Marketing
Organization: Candela Corporation
Phone: +1 949.246.7983
EMail: doranr@candelamedical.com
Layout table for additonal information
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT03430245    
Other Study ID Numbers: DHF24451
First Submitted: January 24, 2018
First Posted: February 12, 2018
Results First Submitted: December 10, 2019
Results First Posted: December 26, 2019
Last Update Posted: January 9, 2020