Winter Garden

Researchers are investigating whether combined treatment using the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices can improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal and aged 40 years or older without other medical causes. This study is a prospective, multi-center, two-arm, single-blinded interventional trial that compares active treatment versus sham treatment to answer if these devices improve depressive symptoms and urinary incontinence. Participants are randomly assigned in a 3:1 ratio to receive either active or sham treatment. The active group receives six transcranial magnetic stimulation sessions with the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, spaced 3 to 7 days apart, along with six treatments using the HPM-6000UF device on pelvic floor muscles at intensities up to 100%. The sham group receives similar sessions but at 1% intensity for both devices. All treatments and visits occur over approximately five months. Throughout the study, participants complete questionnaires assessing depressive symptoms, urinary incontinence, sexual function, mental wellbeing, therapy comfort, and satisfaction. These include the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, and others, administered at baseline, during treatment, and at follow-ups 1 and 3 months after the last session. Researchers monitor changes in subjective depressive symptoms over 15 months to evaluate safety and efficacy.

Objectives 1.) To collect data throughout clinical patient workflow for evaluation of. 1. localization with SmartClip(s) 2. negative margin on primary specimen 3. specimen assessment 4. length of operation The EnVisio® Navigation System was cleared as a Class II device by the FDA under 510(k) number K183400. The SmartClip® Soft Tissue Marker was cleared by the FDA under 510(k) number K180640. Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in. * Date * Time of SmartClip(s) auto detection * Color and Number of SmartClip(s) * Total time of EnVisio Guidance * Specimen Assessment recordings of SmartClip to specimen edge as recorded by electrocautery tip on identified margin Medial/Lateral/Superior/Inferior/Anterior/Posterior) Data will be collected from procedures performed including all imaging, clinical and pathologic outcomes. Pre and Post procedure data including number of individual lesions, localization of mass and number of SmartClips used. Patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study; the AdventHealth Winter Garden location will provide standard informed consent form for the purposes of this study. The projected accrual for this study is 200 patients in total.