Winter Garden

This research aims to evaluate whether the combined use of the EXOMIND BTL-699-2 and EMSELLA HPM-6000UF devices can improve depressive symptoms, sexual function, and urinary incontinence in women who are perimenopausal or postmenopausal, aged 40 years and older, without other medical causes. The study uses a prospective, multi-center, randomized, single-blinded design with two groups to assess safety and efficacy over approximately five months. Participants are randomly assigned in a 31 ratio to either an active treatment group or a sham treatment group. The active group receives six sessions of transcranial magnetic stimulation using the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device applied to pelvic floor muscles at intensities up to 100%. The sham group receives similar procedures at minimal intensities 1%. Treatments are spaced 3 to 7 days apart. During the study, participants complete several assessments including the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, International Consultation on Incontinence Questionnaire, Female Sexual Function Index, Warwick-Edinburgh Mental Wellbeing Scale, Columbia Suicide Severity Rating Scale, Therapy Comfort Questionnaire, and Subject Satisfaction Questionnaire. These are completed at baseline, during treatment, and at follow-ups 1 month and 3 months post-treatment. Researchers monitor changes in depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, satisfaction, and any treatment-related adverse events.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the use of real-time surgical navigation technology to locate and remove soft tissue tumors, specifically in the breast. The study focuses on assessing the efficiency and effectiveness of the EnVisio Surgical Navigation System in guiding surgery to achieve negative margins on the initial tissue specimen. The study plans to enroll 200 female patients undergoing breast conservation therapy for ductal carcinoma in situ DCIS or invasive breast cancer. Participants will undergo breast-conserving surgery using the EnVisio Navigation System combined with SmartClip tissue markers. The system provides intraoperative guidance by detecting SmartClips placed near the tumor, helping surgeons precisely locate and remove the tumor tissue. Data collected includes timing of SmartClip detection, duration of navigation guidance, and specimen margin assessments recorded during surgery. Throughout the study, researchers will collect clinical data, imaging, and pathology results related to tumor localization and surgical outcomes. They will track the number of lesions, number of SmartClips used, and measure margin positivity on the day of surgery. Participants will be monitored as part of their usual clinical care, with data collection integrated into their surgical workflow. The study began in August 2024 and expects to complete by February 2026.