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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…
ClinicalTrials.gov, NCT06983067

Sites

  • Peking University First HospitalBeijing, Beijing Municipality, China