Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eon™ FR Clinical Study Protocol 1064

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898830
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dominion Aesthetic Technologies, Inc.

Brief Summary:
This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.

Condition or disease Intervention/treatment Phase
Fat Disorder Device: eon™ FR 1064 nm device Not Applicable

Detailed Description:
This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single-arm Evaluation of the Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction
Actual Study Start Date : December 8, 2018
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

Arm Intervention/treatment
Experimental: eon™ FR 1064 nm device
Patient will be treated with the eon™ FR 1064 nm device
Device: eon™ FR 1064 nm device
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.




Primary Outcome Measures :
  1. Photographic Evaluations as a Measure of Effectiveness [ Time Frame: 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 Outcome Measures :
  1. Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness [ Time Frame: 12 weeks ]
    Circumferential measurements of the treatment area will be completed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.

  2. Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness [ Time Frame: 12 weeks ]
    Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.

  3. Subject Questionnaire to determine Subject Satisfaction [ Time Frame: 12 weeks ]
    Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) of 30 kg/m2 or less.
  • Healthy male or female between the ages of 21 and 60.
  • Had, at least 25 mm thickness adipose tissue on abdomen.
  • Able to read, understand and sign the Informed Consent Form (ICF).
  • Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Willing to have limited sun exposure for the duration of the study, including the follow-up period.
  • Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications.
  • Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
  • Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
  • Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.

Exclusion Criteria:

  • Aesthetic fat reduction procedure in the treatment area within the previous year.
  • Age less than 21 or greater than 60 years old.
  • Female subject pregnant or planning to become pregnant during the study duration,
  • Had an infection, dermatitis or a rash in the treatment area.
  • Had tattoos or jewelry in the treatment area.
  • Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  • Had a history of a known bleeding disorder.
  • Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light.
  • Had known collagen, vascular disease or scleroderma.
  • Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
  • Had underwent a fat reduction procedure in the treatment area within the past 12 months.
  • Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
  • Underwent systemic chemotherapy for the treatment of cancer.
  • Used gold therapy for disorders such as rheumatologic disease or lupus.
  • 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 had any physical or mental condition which might make it unsafe for the subject to participate in this study.
  • Concurrent use of steroids or secondary rheumatoid drugs.
  • Prior liposuction or a tummy tuck in the study area.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898830


Locations
Layout table for location information
United States, California
Laser & Skin Surgery Center of Northern
Sacramento, California, United States, 95816
United States, Florida
Fiala Aesthetics
Altamonte Springs, Florida, United States, 32701
Miami Dermatology & Laser Research
Miami, Florida, United States, 33173
Sponsors and Collaborators
Dominion Aesthetic Technologies, Inc.
Layout table for additonal information
Responsible Party: Dominion Aesthetic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03898830    
Other Study ID Numbers: D0000000135
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dominion Aesthetic Technologies, Inc.:
Adipose tissue, abdominal
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipid Metabolism Disorders
Metabolic Diseases