Eon™ FR Clinical Study Protocol 1064

NCT03898830 | Completed FDA Device

• 1 other identifier: D0000000135
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fat Disorder

Keywords

Adipose tissue, abdominal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness

  12 weeks

• Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness

  12 weeks

• Subject Questionnaire to determine Subject Satisfaction

  12 weeks

Study Arms (1)

eon™ FR 1064 nm device

EXPERIMENTAL

Patient will be treated with the eon™ FR 1064 nm device

Device: eon™ FR 1064 nm device

Interventions

eon™ FR 1064 nm device DEVICE

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

eon™ FR 1064 nm device

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dominion Aesthetic Technologies, Inc.: lead

Study Sites (3)

Laser & Skin Surgery Center of Northern

Sacramento, California, 95816, United States

Location

Fiala Aesthetics

Altamonte Springs, Florida, 32701, United States

Location

Miami Dermatology & Laser Research

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 2, 2019
• Study Start: December 8, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)