Eon® Flanks Safety Clinical Study Protocol

Sponsor

Dominion Aesthetic Technologies, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04797988

Collaborator

(none)

Enrollment

Location

Arm

3.2

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adipose Tissue	Device: eon® FR 1064 nm device	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Eon® Flanks Safety Clinical Study Protocol

Actual Study Start Date :

Feb 6, 2021

Actual Primary Completion Date :

May 15, 2021

Actual Study Completion Date :

May 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Subject Satisfaction [2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fiala Aesthetics	Altamonte Springs	Florida	United States	32701

Sponsors and Collaborators

Dominion Aesthetic Technologies, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominion Aesthetic Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT04797988

Other Study ID Numbers:

D0000000160

First Posted:

Mar 15, 2021

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jun 10, 2021