Clinical trial NCT04797988: Eon® Flanks Safety Clinical Study Protocol
Official title: Eon® Flanks Safety Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adipose Tissue
Lead sponsor: Dominion Aesthetic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety Evaluation eon® treatment of the flanks (Adverse Events)
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Fiala Aesthetics
state: Florida
Study officials:
References:
citation: Fiala T, Lavin P. Safety of a 1064-nm robotic laser system for noninvasive lipolysis of the flanks. Lasers Surg Med. 2022 Jul;54(5):672-681. doi: 10.1002/lsm.23532. Epub 2022 Mar 9.