LIPOLYSISNCT05507528
Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment
A study testing reborn treatment in people with LIPOLYSIS, run by Lightfective Ltd at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- LIPOLYSIS
- What is being tested?
- reborn treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Jun 2022to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Israel2 sites
Herzelia Medical Center - Tal Nachliely clinic
Kiryat Bialik, 3501261
rabin medical center - campus Hasharon
Petah Tikva, 49100
United States1 site
Tennessee Clinical Research Center
Tennessee City, Tennessee, 37215
About this study
Official title: EVALUATION OF THE SAFETY AND EFFICACY OF REBORN LED SYSTEM FOR NON-INVASIVE LIPOLYSIS TREATMENT
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.
Read the detailed description
Body countering and fat reduction treatment are considered to be one of the most popular aesthetic procedures. The Lightfective' ReBorn LED System provides non-invasive fat reduction treatment.
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
- LIPOLYSIS
- Being tested
- reborn treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reborn treatmentDevice
Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: reborn treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat reduction
to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system.
Measured: 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.
Measured: 20 weeks
Secondary outcomes (1)
safety evaluation
The safety of the ReBorn LED System will be demonstrated by serious adverse event during the study.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 Jun 2022
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LIPOLYSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label, prospective, single arm, interventional study
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lightfective Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507528
- Sponsor's protocol ID
- RB-LF-01
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE SAFETY AND EFFICACY OF REBORN LED SYSTEM FOR NON-INVASIVE LIPOLYSIS TREATMENT
- ClinicalTrials.gov ID
- NCT05507528
- Acronym / sponsor ID
- RB-LF-01
- Conditions
- LIPOLYSIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Lightfective LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Body countering and fat reduction treatment are considered to be one of the most popular aesthetic procedures. The Lightfective' ReBorn LED System provides non-invasive fat reduction treatment.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label, prospective, single arm, interventional study
| Arm | Type | Receives |
|---|---|---|
| Reborn treatment group | Experimental | Device: reborn treatmentThe Lightfective ReBorn System is a Diode Light Emitting Diode (LED) System, Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reborn treatmentFat reduction treatments with the ReBorn LED System visit - include the treatment procedure | Device | Reborn treatment group |
Primary outcome
Fat reduction
Time frame: 20 weeks
to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system.
Blinded reviewers evaluation
Time frame: 20 weeks
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.
1 secondary outcome
safety evaluation
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for LIPOLYSIS
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
RecruitingPhase 2
Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance
Insulin Receptor Mutation, Partial Lipodystrophy
RecruitingPhase 3
SGLT2i, Pioglitazone, and Ketone Production in T1D
Type1diabetes
RecruitingPhase 1
SGLTi, Hepatic Glucose Production and Ketogenesis
Type 2 Diabetes
RecruitingPhase 1
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reborn treatment in people with LIPOLYSIS, run by Lightfective Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat reduction (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.