Status:
COMPLETED
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
Lead Sponsor:
Dominion Aesthetic Technologies, Inc.
Conditions:
Abdominal Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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 disruptio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04842110
Start Date
August 24 2019
End Date
December 21 2019
Last Update
April 13 2021
Active Locations (1)
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1
Fiala Aesthetics
Altamonte Springs, Florida, United States, 32701