Adipose Tissue
Conditions
Brief summary
This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.
Detailed description
This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.
Interventions
DEVICEeon® FR 1064 nm device
The subject will be treatment area - flanks, will be treated with the eon device.
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 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* • 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. * Subject has ongoing use of steroids or secondary rheumatoid drugs. * Subject is actively taking psychotropic medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation eon® treatment of the flanks (Adverse Events) | 2 weeks | Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 2 weeks | Subject Questionnaires will be completed by subjects at the end of the study to determine subject satisfaction with the procedure. Subjects will respond using a scale of 1-6, with 1 being extremely satisfied and 6 being extremely dissatisfied. |
Countries
United States
Outcome results
None listed