Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment
NCT ID: NCT05507528
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2022-06-30
2023-11-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
reborn treatment
Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure
Interventions
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reborn treatment
Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure
Eligibility Criteria
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Inclusion Criteria
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
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).
22 Years
ALL
Yes
Sponsors
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Lightfective Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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RB-LF-01
Identifier Type: -
Identifier Source: org_study_id
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