A Prospective, Open-label, Single-Arm Study Evaluating the Sentire C1000 Surgical Robotic System in Ureteral Reconstruction for Benign Ureteral Strictures

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Stenae Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This study is a single-arm, open-label, prospective, non-randomized cohort design including patients aged 18 to 80 years who require upper urinary tract repair. The trial aims to assess surgical outcomes such as treatment success and surgical non-referral rates. The study involves using the Cornerstone C1000 Robotic Surgery System, a minimally invasive device controlled by the surgeon for performing surgeries like pyeloplasty, stenectomy and reanastomosis, bladder reimplantation, and various patch repairs including oral mucosa and appendix patches. Different procedures such as ileal and colonic substitution ureter are also included. The treatment period lasts approximately 9 months, with 6 months for enrollment and 3 months follow-up. Participants will undergo surgery using the robotic system and be monitored for surgery-related outcomes including operating time, blood loss, pain scores, surgeon's physical and mental load, blood transfusion rates, hospital stay length, physician satisfaction, complication rates, adverse events, device defects, readmission, reoperation, and mortality. Follow-up assessments will continue for about 3 months after surgery to evaluate these measures and ensure safety.

Application of the Sentire C1000 for Ureteral Stricture Repair