Eon™ FR Clinical Study Protocol 1064

A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single-arm Evaluation of the Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction

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.

Study Overview

• Status: Completed
• Conditions: Fat Disorder
• Intervention / Treatment: Device: eon™ FR 1064 nm device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Center of Northern
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Fiala Aesthetics
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eon™ FR 1064 nm device; Patient will be treated with the eon™ FR 1064 nm device	Device: eon™ FR 1064 nm device; The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic Evaluations as a Measure of Effectiveness	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness	Circumferential measurements of the treatment area will be completed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.	12 weeks
Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness	Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.	12 weeks
Subject Questionnaire to determine Subject Satisfaction	Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.	12 weeks

Collaborators and Investigators

• Sponsor: Dominion Aesthetic Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2018
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 16, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Adipose tissue, abdominal
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: D0000000135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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