Eon® Flanks Safety Clinical Study Protocol

Dominion Aesthetic Technologies

Status

Completed

Conditions

Adipose Tissue

Treatments

Device: eon® FR 1064 nm device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04797988

D0000000160

Details and patient eligibility

About

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

Full description

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

Enrollment

11 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.