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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reborn treatment | Device | Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat reduction | to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system. | 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. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety evaluation | The safety of the ReBorn LED System will be demonstrated by serious adverse event during the study. | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Clinical Research Center | Tennessee City | Tennessee | 37215 | United States | ||
| Herzelia Medical Center - Tal Nachliely clinic |
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open label, prospective, single arm, interventional study
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| Kiryat Bialik |
| 3501261 |
| Israel |
| rabin medical center - campus Hasharon | Petah Tikva | 49100 | Israel |