Back to resultsEon™ FR 1064 Full Abdomen Clinical Study Protocol
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: eonTM FR 1064 nm device
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity
Eligibility Criteria
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.
Sites / Locations
- Fiala Aesthetics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1064 Full Abdomen
Arm Description
eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Adipose Layer Thickness
Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
Subject Satisfaction
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Full Information
NCT ID
NCT04842110
First Posted
April 8, 2021
Last Updated
April 8, 2021
Sponsor
Dominion Aesthetic Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04842110
Brief Title
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
Official Title
A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 24, 2019 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dominion Aesthetic Technologies, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1064 Full Abdomen
Arm Type
Experimental
Arm Description
eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device
Intervention Type
Device
Intervention Name(s)
Experimental: eonTM FR 1064 nm device
Intervention Description
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Primary Outcome Measure Information:
Title
Photographic Evaluations as a Measure of Effectiveness
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Adipose Layer Thickness
Description
Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
Time Frame
12 weeks
Title
Subject Satisfaction
Description
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fiala Aesthetics
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
We'll reach out to this number within 24 hrs