Looking for volunteers
Application of the Sentire C1000 for Ureteral Stricture Repair
NCT06983067 · Xuesong Li · Updated 21 May 2025
- What is being tested
- Cornerstone C1000 Robotic Surgery System
- For
- Ureteral Stricture; Hydronephrosis
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 50 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started 1 May 2025, ends 1 May 2026. Registered 21 May 2025.
- Results
- None posted yet.
In the researchers' words
The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative…
Sites
- Peking University First HospitalBeijing, Beijing Municipality, China
