Abdominal Obesity
Conditions
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.
Interventions
DEVICEExperimental: eonTM FR 1064 nm device
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Sponsors
Dominion Aesthetic Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluations as a Measure of Effectiveness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adipose Layer Thickness | 12 weeks | Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both. |
| Subject Satisfaction | 12 weeks | Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure. |
Countries
United States
Outcome results
None listed