Trial Outcomes & Findings for VelaShape III & UltraShape Power for Thigh Circumference Reduction (NCT NCT03430245)
NCT ID: NCT03430245
Last Updated: 2020-01-09
Results Overview
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
COMPLETED
NA
16 participants
At 12 weeks after the third treatment (week 16) for each subject
2020-01-09
Participant Flow
Participant milestones
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VelaShape III & UltraShape Power
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.
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
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VelaShape III & UltraShape Power
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.
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Overall Study
Withdrawal by Subject
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6
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
VelaShape III & UltraShape Power for Thigh Circumference Reduction
Baseline characteristics by cohort
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VelaShape III & UltraShape Power
n=32 Number of thighs
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.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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16 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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46.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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16 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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Mean thigh circumference
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62.1 centimeter
STANDARD_DEVIATION 6.0 • n=32 Number of thighs
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PRIMARY outcome
Timeframe: At 12 weeks after the third treatment (week 16) for each subjectPopulation: 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
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Outcome measures
| Measure |
VelaShape III & UltraShape Power
n=18 Number of thighs
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
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Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
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-2.8 centimeter
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: At 2, 4, 8 and 12 weeks after baselinePopulation: 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.
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.
Outcome measures
| Measure |
VelaShape III & UltraShape Power
n=20 Number of Thighs
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
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Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Circumference change at the second treatment
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-0.4 centimeter
Standard Deviation 0.6
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Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Circumference change at the third treatment
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-0.8 centimeter
Standard Deviation 0.7
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Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Circumference change at 8 weeks after baseline
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-1.8 centimeter
Standard Deviation 0.8
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Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Circumference change at 12 weeks after baseline
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-2.2 centimeter
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: At 4, 8 and 12 weeks follow-up visitsPopulation: 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.
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)
Outcome measures
| Measure |
VelaShape III & UltraShape Power
n=9 Participants
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
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Investigator Satisfaction
Investigator satisfaction at 4 week follow-up · (-2) Very unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 4 week follow-up · (-1) Unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 4 week follow-up · (0) No Opinion
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 4 week follow-up · (1) Satisfied
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5 Participants
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Investigator Satisfaction
Investigator satisfaction at 4 week follow-up · (2) Very satisfied
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4 Participants
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Investigator Satisfaction
Investigator satisfaction at 8 week follow-up · (-2) Very unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 8 week follow-up · (-1) Unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 8 week follow-up · (0) No Opinion
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 8 week follow-up · (1) Satisfied
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4 Participants
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Investigator Satisfaction
Investigator satisfaction at 8 week follow-up · (2) Very satisfied
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5 Participants
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Investigator Satisfaction
Investigator satisfaction at 12 week follow-up · (-2) Very unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 12 week follow-up · (-1) Unsatisfied
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 12 week follow-up · (0) No Opinion
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0 Participants
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Investigator Satisfaction
Investigator satisfaction at 12 week follow-up · (1) Satisfied
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2 Participants
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Investigator Satisfaction
Investigator satisfaction at 12 week follow-up · (2) Very satisfied
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7 Participants
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SECONDARY outcome
Timeframe: At 4, 8 and 12 week follow-up visitsPopulation: 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.
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).
Outcome measures
| Measure |
VelaShape III & UltraShape Power
n=9 Participants
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
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Subject Satisfaction
Subject satisfaction at 12 week follow-up · (-2) Very unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 12 week follow-up · (-1) Unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 4 week follow-up · (-2) Very unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 4 week follow-up · (-1) Unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 4 week follow-up · (0) No Opinion
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0 Participants
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Subject Satisfaction
Subject satisfaction at 4 week follow-up · (1) Satisfied
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3 Participants
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Subject Satisfaction
Subject satisfaction at 4 week follow-up · (2) Very satisfied
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6 Participants
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Subject Satisfaction
Subject satisfaction at 8 week follow-up · (-2) Very unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 8 week follow-up · (-1) Unsatisfied
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0 Participants
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Subject Satisfaction
Subject satisfaction at 8 week follow-up · (0) No Opinion
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1 Participants
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Subject Satisfaction
Subject satisfaction at 8 week follow-up · (1) Satisfied
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3 Participants
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Subject Satisfaction
Subject satisfaction at 8 week follow-up · (2) Very satisfied
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5 Participants
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Subject Satisfaction
Subject satisfaction at 12 week follow-up · (0) No Opinion
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0 Participants
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Subject Satisfaction
Subject satisfaction at 12 week follow-up · (1) Satisfied
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2 Participants
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Subject Satisfaction
Subject satisfaction at 12 week follow-up · (2) Very satisfied
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7 Participants
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Adverse Events
VelaShape III & UltraShape Power
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VelaShape III & UltraShape Power
n=16 participants at risk
Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
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Skin and subcutaneous tissue disorders
Blistering
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6.2%
1/16 • Number of events 1 • 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
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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place