At a glance
ClinicalIndex Comparison Record- ✓Female ages 18-75 years old
- ✓ASA Physical Status Class I or II
- ✓Breast Ptosis Class II or III per Eyck et al Rainbow Scale
- ✓Breast cup size A or B
- ✕ASA Physical Status Class III or higher
- ✕Breast ptosis Class IV or more
- ✕Breast cup size C or larger
- ✕Prior surgery or procedure in breast area including implants, skin tightening, or breast reduction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
In Brief
A clinical study evaluating Renuvion APR System for Breast Ptosis. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.
Study Details
Timeline
Interventions
The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland. Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.