Narberth

Researchers are investigating changes in the peritoneal membrane of children and adults undergoing peritoneal dialysis (PD), focusing on fibrosis, vasculopathy, and new blood vessel formation that can lead to PD failure. Unlike adults, children do not have age or diabetes-related tissue changes, making them a unique group for study. This international, prospective study aims to collect detailed biopsy samples from pediatric patients at different treatment stages to better understand PD-associated membrane alterations and their impact on treatment outcomes and related cardiovascular and inflammatory conditions. The study involves obtaining peritoneal biopsy samples during routine clinical procedures such as PD catheter insertion, abdominal surgeries like hernia repairs or catheter exchanges, and at the time of kidney transplantation. Tissue samples include parietal peritoneal and omental tissues. Blood samples will be collected during regular clinical blood draws. The study is observational, with no additional interventional treatments, and aims to correlate tissue changes with PD treatment types and durations. Participants will be monitored through biopsy analyses, blood tests, and clinical data collected during their regular care. The primary outcome is the evaluation of peritoneal vasculopathy measured by lumen vessel ratio after about two years of PD treatment. The research includes children and adults aged from newborn to 90 years, including those with chronic kidney disease stage 5 on PD, post-PD, post-transplant patients, and individuals with normal kidney function undergoing elective abdominal surgery. Safety and consent procedures are carefully followed throughout the study.

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.