Eon™ FR Clinical Study Protocol 1064
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Photographic Evaluations as a Measure of Effectiveness [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
- Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness [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.
- Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness [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.
- Subject Questionnaire to determine Subject Satisfaction [12 weeks]
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body Mass Index (BMI) of 30 kg/m2 or less.
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Healthy male or female between the ages of 21 and 60.
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Had, at least 25 mm thickness adipose tissue on abdomen.
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Able to read, understand and sign the Informed Consent Form (ICF).
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Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
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Willing to have limited sun exposure for the duration of the study, including the follow-up period.
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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.
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Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
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Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
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Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.
Exclusion Criteria:
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Aesthetic fat reduction procedure in the treatment area within the previous year.
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Age less than 21 or greater than 60 years old.
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Female subject pregnant or planning to become pregnant during the study duration,
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Had an infection, dermatitis or a rash in the treatment area.
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Had tattoos or jewelry in the treatment area.
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Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
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Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
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Had a history of a known bleeding disorder.
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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.
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Had known collagen, vascular disease or scleroderma.
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Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
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Had underwent a fat reduction procedure in the treatment area within the past 12 months.
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Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
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Underwent systemic chemotherapy for the treatment of cancer.
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Used gold therapy for disorders such as rheumatologic disease or lupus.
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Participated in a study of another device or drug within three months prior to enrollment or during the study.
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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.
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Concurrent use of steroids or secondary rheumatoid drugs.
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Prior liposuction or a tummy tuck in the study area.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laser & Skin Surgery Center of Northern | Sacramento | California | United States | 95816 |
| 2 | Fiala Aesthetics | Altamonte Springs | Florida | United States | 32701 |
| 3 | Miami Dermatology & Laser Research | Miami | Florida | United States | 33173 |
Sponsors and Collaborators
- Dominion Aesthetic Technologies, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D0000000135