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

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.

Study Overview

• Status: Completed
• Conditions: LIPOLYSIS
• Intervention / Treatment: Device: reborn treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsvi Bahat, M.sc
• Study Contact Backup: Name: Hila Kfir, B.sc

Study Locations

• Israel
  • Kiryat Bialik, Israel, 3501261
    • Herzelia Medical Center - Tal Nachliely clinic
  • Petah tikva, Israel, 49100
    • rabin medical center - campus Hasharon
• United States
  • Tennessee
    • Tennessee, Tennessee, United States, 37215
      • Tennessee Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female subjects > 22 years of age.
2. Subject has clearly visible fat on the flanks area.
3. Subject has not experienced weight change exceeding 4.5kg in the preceding month.
4. Subject agrees to maintain their weight (i.e., within 2.25kg) by not making any major changes in their diet or lifestyle during the course of the study.
5. Subject is willing and able to comply with protocol requirements and all study visits
6. Subject has provided a written informed consent

Exclusion Criteria:

1. Subject underwent a prior surgical procedure(s) in the area of intended treatment within the past 6 months.
2. Subject underwent a prior invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
3. Subject underwent a prior non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
4. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., clexane, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of bleeding disorder, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject body mass index (BMI) exceeds 30. BMI is defined as weight in kg divided by the square of the height in cm.
9. Subject is taking or has taken diet pills or supplements within the past month.
10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
11. Subject is pregnant or intending to become pregnant in the next 6 months.
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
16. Subject is currently taking weight reduction medications (e.g., Saxenda).
17. Subject is currently taking GLP-1 receptor agonist medications (e.g., Victoza).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reborn treatment group; The Lightfective ReBorn System is a Diode Light Emitting Diode (LED) System, Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure	Device: reborn treatment; Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat reduction	to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system.	20 weeks
Blinded reviewers evaluation	subject's pre and post-treatment photographs will be presented in randomized order to blinded reviewers for evaluation. Subject is considered "success" if at least two out of the three evaluators correctly identify photographs order.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety evaluation	The safety of the ReBorn LED System will be demonstrated by serious adverse event during the study.	20 weeks

Collaborators and Investigators

• Sponsor: Lightfective Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): November 11, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RB-LF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes