LED Device for Non-Invasive Lipolysis
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|ClinicalTrials.gov Identifier: NCT03171051|
Recruitment Status : Terminated (device development placed on hold)
First Posted : May 31, 2017
Results First Posted : October 14, 2020
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lipolysis||Device: 950 nm LED Device Device: 1050nm Diode Laser Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects to receive the same treatments - right flank of abdomen with the experimental LED device and the left flank of the abdomen with the active comparator diode laser device.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study of a 950 nm Wavelength LED Device for Non-Invasive Lipolysis of the Flanks|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||May 16, 2019|
|Actual Study Completion Date :||May 16, 2019|
The right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.
The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.
Device: 950 nm LED Device
Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.
Device: 1050nm Diode Laser Device
FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Other Name: SculpSure
- Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths [ Time Frame: At time of treatment ]Immediately (within 2 minutes) after treatment of the area, 3 sterile thermocouple needles of different lengths (9.5-14 mm), will be inserted into the center of each applicator footprint. Temperature readings from each thermocouple needle will be recorded.
- Visual Analog Scale (VAS) [ Time Frame: Time of treatment ]Subjects reported level of discomfort and pain after treatment with LED and Laser applicators on a 10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 'no pain at all' (value of 0 cm) and 'worst pain imaginable' (value of 10 cm).
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): NCT03171051
|United States, New York|
|Sadick Research Group|
|New York, New York, United States, 10075|
|Study Director:||Yoni Iger, PhD||Venus Concept Ltd.|