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 : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : August 23, 2018
|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 :||10 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 :||January 15, 2018|
|Estimated Primary Completion Date :||January 15, 2019|
|Estimated Study Completion Date :||January 15, 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, the newest generation VelaShape, is a device based on the CE-cleared VelaShape II and FDA-cleared Transcend device (K120510). All devices combine controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum. The VelaShape III device is indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs and abdomen circumference.
The VelaShape III device has 150W RF energy.
Device: UltraShape Power
The newest generation UltraShape device, UltraShape Power, includes a small transducer (U-Sculpt Power), and is FDA-cleared (K170370) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.
- Circumference reduction 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 reduction post combined VelaShape III and UltraShape Power treatments
- Circumference reduction in the thighs after each treatment and at follow-ups compared to baseline [ Time Frame: At 2, 4, 8, 12 and 16 weeks for each subject ]Circumference reduction post combined VelaShape III and UltraShape Power treatments
- Investigator satisfaction [ Time Frame: At 8, 12 and 16 weeks for each subject ]Investigator satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied
- Subject satisfaction [ Time Frame: At 8, 12 and 16 weeks for each subject ]Subject satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied
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|