Eon® Flanks Safety Clinical Study Protocol

Completed · Not applicable

Conditions studied: Adipose Tissue

In brief

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

Key facts

Study ID

NCT04797988

Run by

Dominion Aesthetic Technologies, Inc.

People needed

11

Starts

2021-02-06

Expected to finish

2021-05-15

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• • 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.

Where it is running

• Fiala Aesthetics — Altamonte Springs, Florida, United States

Full record on ClinicalTrials.gov

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