Eon® Flanks Safety Clinical Study Protocol

NCT04797988 | Completed FDA Device

• 1 other identifier: D0000000160
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject Satisfaction

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

eon FR 1064 nm Device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dominion Aesthetic Technologies, Inc.: lead

Study Sites (1)

Fiala Aesthetics

Altamonte Springs, Florida, 32701, United States

Location

Related Publications (1)

• 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.

  PMID: 35266172 DERIVED

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 10, 2021
• First Posted: March 15, 2021
• Study Start: February 6, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)