Dunedin

Researchers are evaluating the Erchonia GVS laser as a non-invasive treatment aimed at improving the appearance of skin laxity in the abdominal area. This clinical study uses a prospective open-label design with independent blinded evaluations after treatment to assess the laser's effectiveness in reducing mild to moderate skin laxity. Participants will receive eight treatments using the Erchonia GVS Laser, which delivers 405nm violet and 520nm green laser light therapy, over a period of four weeks. This device-based therapy focuses on enhancing skin appearance without surgery or invasive procedures. During the study, participants will have photographs taken before and after treatment, which will be assessed by blinded independent evaluators. Researchers will monitor adherence to treatment schedules and evaluate the proportion of accurately identified pre- and post-treatment images at 12 weeks. Participants will be followed through all study visits and evaluations to understand the treatment's impact on skin laxity.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.