Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment

NCT05507528 | Completed FDA Device

• 1 other identifier: RB-LF-01
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 3

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.

Conditions

LIPOLYSIS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• safety evaluation

  20 weeks

Study Arms (1)

Reborn treatment group

EXPERIMENTAL

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

Interventions

reborn treatment DEVICE

Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure

Reborn treatment group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects \> 22 years of age.
• Subject has clearly visible fat on the flanks area.
• Subject has not experienced weight change exceeding 4.5kg in the preceding month.
• 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.
• Subject is willing and able to comply with protocol requirements and all study visits
• Subject has provided a written informed consent

You may not qualify if:

• Subject underwent a prior surgical procedure(s) in the area of intended treatment within the past 6 months.
• Subject underwent a prior invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
• Subject underwent a prior non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
• Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., clexane, insulin) within the past month.
• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• 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.
• 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.
• Subject body mass index (BMI) exceeds 30. BMI is defined as weight in kg divided by the square of the height in cm.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
• Subject is pregnant or intending to become pregnant in the next 6 months.
• Subject is lactating or has been lactating in the past 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• 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.

Sponsors & Collaborators

• Lightfective Ltd: lead

Study Sites (3)

Tennessee Clinical Research Center

Tennessee City, Tennessee, 37215, United States

Location

Herzelia Medical Center - Tal Nachliely clinic

Kiryat Bialik, 3501261, Israel

Location

rabin medical center - campus Hasharon

Petah Tikva, 49100, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label, prospective, single arm, interventional study

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: June 30, 2022
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (1)