Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:13 PM
Study NCT ID:
NCT05507528
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2022-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment
Sponsor:
Lightfective Ltd
Organization:
Study Overview
Official Title:
EVALUATION OF THE SAFETY AND EFFICACY OF REBORN LED SYSTEM FOR NON-INVASIVE LIPOLYSIS TREATMENT
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: