CompletedNot Applicable

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

United States, Israel107 participantsStarted 2022-06-30

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Fat reduction

Timeframe: 20 weeks

Blinded reviewers evaluation

Timeframe: 20 weeks

Trial details

NCT IDNCT05507528

SponsorLightfective Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-11

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