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
|Condition or disease||Intervention/treatment||Phase|
|Circumference Reduction||Device: VelaShape III Device: UltraShape Power||Not Applicable|
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.
Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction|
|Actual Study Start Date :||February 19, 2018|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||July 3, 2019|
Experimental: VelaShape III & UltraShape Power
VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment.
Device: VelaShape III
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
Device: UltraShape Power
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
- Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements [ Time Frame: At 12 weeks after the third treatment (week 16) for each subject ]Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
- Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits [ Time Frame: At 2, 4, 8 and 12 weeks after baseline ]
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.
- Investigator Satisfaction [ Time Frame: At 4, 8 and 12 weeks follow-up visits ]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)
- Subject Satisfaction [ Time Frame: At 4, 8 and 12 week follow-up visits ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430245
|United States, New Jersey|
|Skin Laser & Surgery Specialist of NY/NJ|
|Hackensack, New Jersey, United States, 07601|