- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04842110
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
April 8, 2021 updated by: Dominion Aesthetic Technologies, Inc.
A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect.
This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Altamonte Springs, Florida, United States, 32701
- Fiala Aesthetics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (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 abdomen.
- Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
- Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area.
- Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs.
- Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
- Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period.
- Subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications.
- Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized.
Exclusion Criteria:
- Aesthetic fat reduction procedure in the treatment area within the previous year.
- Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
- Unstable weight within the last 6 months (+ or - 3% weight change in the prior six 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1064 Full Abdomen
eonTM FR 1064 nm device Patient will be treated with the eonTM 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
Time Frame: 12 Weeks
|
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 |
---|---|---|
Change in Adipose Layer Thickness
Time Frame: 12 weeks
|
Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
|
12 weeks
|
Subject Satisfaction
Time Frame: 12 weeks
|
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 24, 2019
Primary Completion (ACTUAL)
December 21, 2019
Study Completion (ACTUAL)
December 21, 2019
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 8, 2021
First Posted (ACTUAL)
April 13, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 8, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0000000151
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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