MedTrace Logo

Application of the Sentire C1000 for Ureteral Stricture Repair

NCT06983067 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-05-21

No results posted yet for this study

Summary

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 patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate.

The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months.

Conditions

  • Ureteral Stricture
  • Hydronephrosis

Interventions

DEVICE

Cornerstone C1000 Robotic Surgery System

Minimally invasive surgical instruments are controlled by the physician using a master-slave operating system for urologic laparoscopic surgical operations.

Sponsors & Collaborators

  • Xuesong Li

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-03-01
Completion
2026-05-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983067 on ClinicalTrials.gov