Adipose Tissue Clinical Trial
Official title:
Eon® Flanks Safety Clinical Study Protocol
Verified date | June 2021 |
Source | Dominion Aesthetic Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.
Status | Completed |
Enrollment | 11 |
Est. completion date | May 15, 2021 |
Est. primary completion date | May 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Fiala Aesthetics | Altamonte Springs | Florida |
Lead Sponsor | Collaborator |
---|---|
Dominion Aesthetic Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Evaluation eon® treatment of the flanks (Adverse Events) | Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment. | 2 weeks | |
Secondary | Subject Satisfaction | 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. | 2 weeks |
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