Eon® Flanks Safety Clinical Study Protocol | NCT04797988

NCT04797988

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
eon FR 1064 nm Device	Experimental	Patient will be treated with the eon FR 1064 nm device.	Device: eon® FR 1064 nm device

Name	Type	Description	Arm Group Labels	Other Names
eon® FR 1064 nm device	Device	The subject will be treatment area - flanks, will be treated with the eon device.	eon FR 1064 nm Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.