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Non-invasive Lipolysis Device
REBORN Lipolysis for Fat Reduction
N/A
Waitlist Available
Research Sponsored by Lightfective Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Study Summary
This trial procedure uses a device to reduce fat bulges in the flanks in people with a BMI under 30.
Who is the study for?
This trial is for men and women over 22 with a BMI of 30 or less, who haven't had significant weight changes recently. Participants must not plan major diet/lifestyle changes during the study, have visible flank fat, and agree to follow the study rules. Pregnant individuals or those with certain medical conditions/treatments in the target area are excluded.Check my eligibility
What is being tested?
The Lightfective ReBorn System is being tested for its ability to non-invasively break down fat in the flanks (side areas around the waist). The system aims to reduce visible fat bulges without surgery.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include skin reactions at treatment sites, temporary numbness or discomfort, bruising, swelling, and sensitivity to cold due to exposure from treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blinded reviewers evaluation
Fat reduction
Secondary outcome measures
safety evaluation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Reborn treatment groupExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
reborn treatment
2022
N/A
~110
Find a Location
Who is running the clinical trial?
Lightfective LtdLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of bleeding problems or are taking medications that might make you more likely to bruise.You have taken diet pills or supplements in the last month.You have noticeable fat on your sides (flanks).You have a medical history of certain conditions that are triggered by exposure to cold temperatures.You have a condition called Reynaud's disease or any other condition that affects blood flow to the skin in response to cold exposure.You are currently taking medications to help you lose weight (like Saxenda).You are currently taking medications like Victoza that belong to a group called GLP-1 receptor agonists.
Research Study Groups:
This trial has the following groups:- Group 1: Reborn treatment group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are encompassed by this experiment?
"Affirmative, the information on clinicaltrials.gov reveals that recruitment for this trial has been ongoing since June 30th 2022; with the most recent edit made July 24th 2023. The medical study is targeting 72 patients across 3 sites."
Answered by AI
Is enrollment for this trial still accessible at the present moment?
"Affirmative. Clinicaltrials.gov provides information that this medical trial, initially posted on June 30th 2022 is actively enrolling participants. A total of 72 subjects must be recruited from 3 different sites."
Answered by AI
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