Eon™ FR 1064 Full Abdomen Clinical Study Protocol

• ClinicalTrials.gov Identifier: NCT04842110
• Recruitment Status: Completed
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Sponsor: Dominion Aesthetic Technologies, Inc.
• Information provided by (Responsible Party): Dominion Aesthetic Technologies, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Abdominal Obesity	Device: Experimental: eonTM FR 1064 nm device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
• Actual Study Start Date: August 24, 2019
• Actual Primary Completion Date: December 21, 2019
• Actual Study Completion Date: December 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1064 Full Abdomen; eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device	Device: Experimental: eonTM FR 1064 nm device; The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

Outcome Measures

Primary Outcome Measures :

1. Photographic Evaluations as a Measure of Effectiveness [ Time Frame: 12 Weeks ]
   Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device.

Secondary Outcome Measures :

1. Change in Adipose Layer Thickness [ Time Frame: 12 weeks ]
   Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
2. Subject Satisfaction [ Time Frame: 12 weeks ]
   Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Fiala Aesthetics

Altamonte Springs, Florida, United States, 32701

Sponsors and Collaborators

Dominion Aesthetic Technologies, Inc.

More Information

• Responsible Party: Dominion Aesthetic Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT04842110
• Other Study ID Numbers: D0000000151
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Obesity, Abdominal; Obesity; Overnutrition; Nutrition Disorders