Eon® Flanks Safety Clinical Study Protocol

Study Overview
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Brief Summary
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This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Detailed Description
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This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Official Title
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Eon® Flanks Safety Clinical Study Protocol

Conditions
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Adipose Tissue

Intervention / Treatment
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* Device: eon® 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 flanks. Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English. Subject has sufficient thickness (≥ 20 mm) of adipose tissue on the flanks area. Subject must be willing and able to adhere to the treatment and follow-up visit schedule. Subject is willing to have photographs and ultrasound measurements taken of the treated area. Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, or surgically sterilized. Exclusion Criteria: • Subject had an aesthetic fat reduction procedure in the treatment area within the previous year Subject was pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 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
Maximum Age: 99 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: eon FR 1064 nm Device<br>Patient will be treated with the eon FR 1064 nm device. | Device: eon® FR 1064 nm device<br>* The subject will be treatment area - flanks, will be treated with the eon device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation eon® treatment of the flanks (Adverse Events) | Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Subject Questionnaires will be completed by subjects at the end of the study to determine subject satisfaction with the procedure. Subjects will respond using a scale of 1-6, with 1 being extremely satisfied and 6 being extremely dissatisfied. | 2 weeks |