Clifton

Researchers are investigating Barrigel, a biodegradable gel, designed to temporarily separate the front wall of the rectum from the prostate or prostate bed during radiotherapy for prostate cancer. This study focuses on men who have prostate cancer recurrence after prostate removal surgery and aims to see if Barrigel can reduce the radiation dose delivered to the rectum during treatment. The trial is a prospective, randomized, controlled, and single-masked multicenter study evaluating the safety and effectiveness of Barrigel in this setting. Barrigel, made from Non-Animal Stabilized Hyaluronic Acid (NASHA143), is injected into the space between the rectum and prostate bed to create separation. All participants will undergo a transrectal ultrasound (TRUS); for those receiving Barrigel, the ultrasound helps guide the injection, while for controls, it serves as a sham procedure. The gel is absorbable and maintains space throughout the course of intensity-modulated radiation therapy (IMRT) aimed at treating prostate cancer recurrence after prostatectomy. Participants will be monitored closely with imaging and clinical assessments, including scans to check for cancer spread before enrollment. Researchers will measure the reduction in radiation dose to the rectum three months after treatment begins. Safety and adherence to the protocol will be followed, with participation involving informed consent and ongoing evaluation to ensure treatment completion and monitor for side effects.

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.

Researchers are evaluating the Shield blood test as a screening tool for colorectal cancer (CRC) in people aged 45 to 81 who are at average risk for CRC. This study aims to assess how well the Shield test performs during a second round of testing, using colonoscopy as the standard comparison. Colorectal cancer is a common and serious disease, especially in older adults, and early detection through screening can reduce mortality by catching cancer at earlier, more treatable stages. Participants will undergo the Shield blood test as part of their standard care. The study focuses on average-risk individuals who do not have symptoms or high-risk factors for CRC. The performance of the Shield test will be monitored over a period of 33 to 42 months after enrollment to evaluate its effectiveness compared to colonoscopy results. During the study, participants will follow study procedures and standard care assessments. Researchers will measure the performance of the Shield test in detecting colorectal cancer and its precursors during the second testing interval. This includes ongoing monitoring and data collection to understand the test's accuracy and reliability in a real-world setting, with a total follow-up period extending beyond two and a half years.