Stanford Study on Safety and Effectiveness of da Vinci Xi Robotic Surgery in Children and Adolescents Aged 6 to 21

What this Trial Is About

This research aims to evaluate the safety, performance, and feasibility of the da Vinci Xi Surgical System in pediatric and adolescent patients undergoing various surgical procedures. The trial seeks to confirm that this robotic system is comparable to existing surgical methods. Conducted with Stanford Universitys IRB approval, the study includes children and young adults aged 6 to 21 years, focusing on a range of surgeries from sleeve gastrectomy to laryngoplasty. The study has two sequential groups Arm 1 involves robotic surgeries with established adult models or prior preclinical support, including procedures like cholecystectomy and thoracic tracheoplasty. Arm 2, starting after Arm 1 completion, includes more complex surgeries such as bronchoplasty and proctectomy with ileal pouch-anal anastomosis. Additionally, there is a registry for patients receiving standard non-robotic care for comparison. Participants are monitored from pre-operative assessments through 7 weeks post-operation. Participants will undergo evaluations before and after surgery to assess outcomes like intraoperative performance and device-related adverse events. Quality of life will be measured using the Pediatric Quality of Life Inventory from enrollment until 7 weeks after surgery. The study is non-randomized and unblinded, and aims to gather comprehensive data on robotic surgerys impact in this young population.

Stanford Program to Accelerate Robotic Children's Surgery