Eon® Flanks Safety Clinical Study Protocol

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

Study Overview

• Status: Completed
• Conditions: Adipose Tissue
• Intervention / Treatment: Device: eon® FR 1064 nm device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Fiala Aesthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• • 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.

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 will be treatment area - flanks, will be treated with the eon device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation eon® treatment of the flanks (Adverse Events)	Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction	Subject Questionnaires will be completed by subjects at the end of the study to determine subject satisfaction with the procedure. Subjects will respond using a scale of 1-6, with 1 being extremely satisfied and 6 being extremely dissatisfied.	2 weeks

Collaborators and Investigators

• Sponsor: Dominion Aesthetic Technologies, Inc.

Publications and helpful links

General Publications

• Fiala T, Lavin P. Safety of a 1064-nm robotic laser system for noninvasive lipolysis of the flanks. Lasers Surg Med. 2022 Jul;54(5):672-681. doi: 10.1002/lsm.23532. Epub 2022 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D0000000160

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