Bay St. Louis

Researchers are evaluating the efficacy and safety of MELT-300, a sublingual tablet containing midazolam and ketamine, for procedural sedation in adults undergoing cataract extraction with lens replacement (CELR). This Phase 3, randomized, double-masked, placebo-controlled study includes an active comparator, sublingual midazolam, to assess the contribution of ketamine in MELT-300. The study aims to compare MELT-300 with placebo and midazolam to understand sedation effectiveness, time to sedation, and safety concerns during cataract surgery. Participants will be randomly assigned to one of three groups: MELT-300, midazolam alone, or placebo. Each participant will receive one sublingual tablet 30 (±5) minutes before surgery, without food or water, just prior to the administration of topical ocular anesthetic gel. The study involves a single day of treatment and surgery, with sedation evaluated before, during, and at the end of the surgery. Participants will be admitted on Day 1 for surgery and medication administration. Researchers will monitor sedation success, need for rescue medications, and surgery completion. Safety assessments, including monitoring adverse events, vital signs, and physical exams, will occur at baseline, during surgery, postoperatively on Day 1, and on Day 3 (±1 day). Approximately 528 adults aged 18 to 65 will participate, with follow-up to assess both efficacy and safety outcomes.

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.