Trials / Completed
CompletedNCT05507528
Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment
EVALUATION OF THE SAFETY AND EFFICACY OF REBORN LED SYSTEM FOR NON-INVASIVE LIPOLYSIS TREATMENT
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Lightfective Ltd · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The Lightfective ReBorn System is intended for non-invasive lipolysis of the flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the flanks.
Detailed description
Body countering and fat reduction treatment are considered to be one of the most popular aesthetic procedures. The Lightfective' ReBorn LED System provides non-invasive fat reduction treatment. The primary efficacy objective is to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system. study population, Healthy subjects who seek for fat reduction treatments in the flanks area. Each subject will undergo 2 treatment visits (one month apart) and follow-up visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | reborn treatment | Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure |
Timeline
- Start date
- 2022-06-30
- Primary completion
- 2023-11-11
- Completion
- 2023-11-11
- First posted
- 2022-08-19
- Last updated
- 2024-02-15
Locations
3 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05507528. Inclusion in this directory is not an endorsement.