Eon™ FR 1064 Full Abdomen Clinical Study Protocol

Study Overview
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Brief Summary
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This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.

Official Title
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A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat

Conditions
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Abdominal Obesity

Intervention / Treatment
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* Device: Experimental: eonTM FR 1064 nm device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the abdomen. Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English. Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area. Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs. Subject must be willing and able to adhere to the treatment and follow-up visit schedule. Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period. Subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications. Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized. Exclusion Criteria: Aesthetic fat reduction procedure in the treatment area within the previous year. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months) Subject has an infection, dermatitis or a rash in the treatment area. Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame. Subject has a history of keloid scarring, hypertrophic scarring or of abnormal wound healing. Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. Subject has a history of a known bleeding disorder. Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light. Subject has known collagen, vascular disease or scleroderma. Subject has undergone a surgery or procedure in the treatment area within 6 months of treatment, which is still healing. Subject suffers from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy. Subject is undergoing systemic chemotherapy for the treatment of cancer. Subject is using gold therapy for disorders such as rheumatologic disease or lupus. Subject has participated in a study of another device or drug within three months prior to enrollment or during the study. As per the investigator's discretion, the subject has any physical or mental condition which might make it unsafe for the subject to participate in this study. Subject has ongoing use of steroids or secondary rheumatoid drugs. Subject is actively taking psychotropic medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1064 Full Abdomen<br>eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device | Device: Experimental: eonTM FR 1064 nm device<br>* The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Evaluations as a Measure of Effectiveness | Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adipose Layer Thickness | Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both. | 12 weeks | 
| Subject Satisfaction | Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure. | 12 weeks |