This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.
The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Jacob G Unger MD
Nashville, Tennessee, United States
Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)
Regular and 3D Vectra photos will be taken at all time points. Additional evaluation of changes in breast shape, including upper pole fullness, breast projection, and bottoming out will be assessed by static measurements (cm) of: * Sternal Notch to Nipple * Nipple to Inframammary Fold (IMF) * Base Width (at point of breast take off from chest wall) * Nipple to nipple
Time frame: 12 months
Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatment and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items.
Time frame: 12 months
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