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

Completed · Not applicable

Conditions studied: LIPOLYSIS

In brief

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.

Key facts

Study ID

NCT05507528

Run by

Lightfective Ltd

People needed

107

Starts

2022-06-30

Expected to finish

2023-11-11

Last updated by the study team

2024-02-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

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.
• Subject is currently taking weight reduction medications (e.g., Saxenda).
• Subject is currently taking GLP-1 receptor agonist medications (e.g., Victoza).

Where it is running

• Tennessee Clinical Research Center — Tennessee City, Tennessee, United States
• Herzelia Medical Center - Tal Nachliely clinic — Kiryat Bialik, Israel
• rabin medical center - campus Hasharon — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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