To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
The Primary Objectives of this protocol are to evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency for use in aesthetic dermatological procedures requiring the ablation, excision, incision, or coagulation of soft tissue. Efficacy will be analyzed through histological and molecular analysis. Safety will be analyzed by monitoring the occurrence of any adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
The Venus Bliss™ system is an aesthetic medical device designed to non-invasively reduce subcutaneous adipose tissue of the abdominal area and flanks. It is intended for use in individuals with a Body Mass Index (BMI) of 30 or less. The device consists of an external treatment component and an internal control component. The treatment console is a 1060nm diode laser applicator and a radio frequency applicator. In addition, a Bliss Belt is provided with the system to properly secure one or more applicators to the patient's body during treatment. Finally, the touchscreen monitor is used by the clinician to control the setting display on the main console. It also keeps the clinician informed of the device's status and operating parameters.
Dr. Brian Kinney Plastic Surgeon
Beverly Hills, California, United States
University of Texas Southwestern
Dallas, Texas, United States
Changes in elastin as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in collagen as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in hyaluronic acid as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in elastin as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in collagen as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
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Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Quantification of the immune response following treatment
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to the immune response.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment