Eon™ FR Clinical Study Protocol 1064
|ClinicalTrials.gov Identifier: NCT03898830|
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fat Disorder||Device: eon™ FR 1064 nm device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898830
|United States, California|
|Laser & Skin Surgery Center of Northern|
|Sacramento, California, United States, 95816|
|United States, Florida|
|Altamonte Springs, Florida, United States, 32701|
|Miami Dermatology & Laser Research|
|Miami, Florida, United States, 33173|