eon™ fr clinical study protocol 1064

Conditions: Fat Disorder

Summary: this study evaluates the treatment of subjects with the eon™ fr 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.

this study evaluates the treatment of subjects between 18-60 with the eon™ fr 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 30 kg/m2 or less. * healthy male or female between the ages of 21 and 60. * had, at least 25 mm thickness adipose tissue on abdomen. * able to read, understand and sign the informed consent form (icf). * willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. * willing to have limited sun exposure for the duration of the study, including the follow-up period. * willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications. * female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study. * female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative. * agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight. exclusion criteria: * aesthetic fat reduction procedure in the treatment area within the previous year. * age less than 21 or greater than 60 years old. * female subject pregnant or planning to become pregnant during the study duration, * had an infection, dermatitis or a rash in the treatment area. * had tattoos or jewelry in the treatment area. * had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing. * had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. * had a history of a known bleeding disorder. * had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light. * had known collagen, vascular disease or scleroderma. * underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing. * had underwent a fat reduction procedure in the treatment area within the past 12 months. * had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy. * underwent systemic chemotherapy for the treatment of cancer. * used gold therapy for disorders such as rheumatologic disease or lupus. * 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 had any physical or mental condition which might make it unsafe for the subject to participate in this study. * concurrent use of steroids or secondary rheumatoid drugs. * prior liposuction or a tummy tuck in the study area.

Keywords: adipose tissue, abdominal