Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03171051
Brief Summary:
This study is being conducted to evaluate the ability of a light emitting diode (LED) study device's ability to raise the temperatures on flank tissue to a similar level compared to an approved laser device (SculpSure by Cynosure). Laser treatments have 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.
Detailed Description:
This is an open-label, feasibility study comparing the tissue temperature profile of a 950 nm LED device and a 1060 nm diode laser for non-invasive lipolysis of the flanks. The study will enroll up to 10 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single treatment with each device on opposite flanks. Tissue temperatures in the treated areas will be recorded at various tissue depths and compared. Subjects will be asked to assess their discomfort and pain of the study treatment using a 10 cm visual analog scale (VAS). In addition, the safety (number of treatment related adverse events) of the LED device will be compared to the reference device at the time of treatment and one week later.
Study:
NCT03171051
Study Brief:
Protocol Section:
NCT03171051