Eon™ FR 1064 Full Abdomen Clinical Study Protocol

NCT ID: NCT04842110

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-24
• Study Completion Date: 2019-12-21

Brief Summary

This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.

Conditions

Abdominal Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1064 Full Abdomen

eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device

Group Type: EXPERIMENTAL

Experimental: eonTM FR 1064 nm device

Intervention Type: DEVICE

The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

Interventions

Experimental: eonTM FR 1064 nm device

The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the abdomen.
• Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
• Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area.
• Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs.
• Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
• Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period.
• Subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications.
• Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized.

Exclusion Criteria

• Aesthetic fat reduction procedure in the treatment area within the previous year.
• Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
• Unstable weight within the last 6 months (+ or - 3% weight change in the prior six 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dominion Aesthetic Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fiala Aesthetics

Altamonte Springs, Florida, United States

Countries

United States

Other Identifiers

D0000000151

Identifier Type: -

Identifier Source: org_study_id