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Eon™ FR Clinical Study Protocol 1064

Primary Purpose

Fat Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eon™ FR 1064 nm device
Sponsored by
Dominion Aesthetic Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fat Disorder focused on measuring Adipose tissue, abdominal

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Laser & Skin Surgery Center of Northern
  • Fiala Aesthetics
  • Miami Dermatology & Laser Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eon™ FR 1064 nm device

Arm Description

Patient will be treated with the eon™ FR 1064 nm device

Outcomes

Primary Outcome Measures

Photographic Evaluations as a Measure of Effectiveness
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

Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness
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.
Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.
Subject Questionnaire to determine Subject Satisfaction
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.

Full Information

First Posted
March 28, 2019
Last Updated
May 16, 2020
Sponsor
Dominion Aesthetic Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03898830
Brief Title
Eon™ FR Clinical Study Protocol 1064
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 8, 2018 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dominion Aesthetic Technologies, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Disorder
Keywords
Adipose tissue, abdominal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eon™ FR 1064 nm device
Arm Type
Experimental
Arm Description
Patient will be treated with the eon™ FR 1064 nm device
Intervention Type
Device
Intervention Name(s)
eon™ FR 1064 nm device
Intervention Description
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Primary Outcome Measure Information:
Title
Photographic Evaluations as a Measure of Effectiveness
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness
Description
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.
Time Frame
12 weeks
Title
Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness
Description
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.
Time Frame
12 weeks
Title
Subject Questionnaire to determine Subject Satisfaction
Description
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Laser & Skin Surgery Center of Northern
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Fiala Aesthetics
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Miami Dermatology & Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Eon™ FR Clinical Study Protocol 1064

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