Eon™ FR Clinical Study Protocol 1064

Dominion Aesthetic Technologies

Status

Completed

Conditions

Fat Disorder

Treatments

Device: eon™ FR 1064 nm device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03898830

D0000000135

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.