Application of the Sentire C1000 for Ureteral Stricture Repair

NCT06983067 | Recruiting DMC

• 1 other identifier: F-00882-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Surgical non-transfer rate

  Surgical non-transfer rate is defined as failure to switch from the test medical device (Laparoendoscopic Surgical System) assisted approach to other surgical device control system assisted, laparoscopic surgery or open surgery. Surgical non-referral rate = number of subjects whose surgery was not referred/total number of subjects x 100%.

  During the surgery

• Success rate of surgical treatment

  At 3 months postoperatively, surgical treatment was considered successful when the following conditions were also met: * No ureteral obstruction on investigator-assessed imaging and no deterioration/progression of renal function from baseline. * No interventions (endoluminal dilatation, surgical interventions, etc.) for disease progression or recurrence after study treatment, except for interventions for complications of the surgery Success rate of surgical treatment = number of subjects with successful surgical treatment/total number of subjects × 100%.

  3 months postoperatively

Secondary Outcomes (9)

• Installation time

  During the surgery

• Surgeon operating time

  During the surgery

• Estimated blood loss

  During the surgery

• Postoperative patient pain scores

  During the surgery

• Evaluation of intraoperative physiologic load by the surgeon

  During the surgery

Other Outcomes (7)

• Overall complication rate at 3 months postoperatively

  3 months postoperatively

• Adverse events

  3 months postoperatively

• Serious adverse event

  3 months postoperatively

Study Arms (3)

Simple anastomosis reconstruction group

Including pyeloplasty, stenectomy and reanastomosis, and bladder reimplantation

Device: Cornerstone C1000 Robotic Surgery System

Patch Repair Group

Includes oral mucosa, appendix patches, etc.

Device: Cornerstone C1000 Robotic Surgery System

Intestinal/ileal Substitute Ureteral Group

These include the ileal substitution ureter and colonic substitution ureter procedures.

Device: Cornerstone C1000 Robotic Surgery System

Interventions

Cornerstone C1000 Robotic Surgery System DEVICE

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

Intestinal/ileal Substitute Ureteral Group; Patch Repair Group; Simple anastomosis reconstruction group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligibility criteria for enrollment in 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 as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or whose guardian agrees to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations.

You may qualify if:

• (1) Patients aged ≥18 years and ≤80 years, male or female; (2) Patients who need to undergo upper urinary tract repair surgery; (3) Patients who are suitable for ureteral reconstruction as confirmed by the investigator; (4) Subjects who voluntarily participate in the clinical trial and agree or whose guardians agree and sign the informed consent form; (5) Willing to cooperate and complete the trial follow-up and related examinations.

You may not qualify if:

• (1) Presence of severe drug/imaging contrast allergy; (2) Patients with a history of pelvic/abdominal surgery and assessed for extensive severe adhesions; (3) Those with a previous history of other malignancies and judged by the investigator to be unsuitable for enrollment; (4) Diseases that are not expected to tolerate pneumoperitoneum or prolonged head-down-foot-up position, or diseases that do not allow intraoperative positioning, such as spinal deformity or ankylosing spondylitis; (5) Those with serious comorbidities (heart, lung, liver, brain, kidney and other diseases) and those who are physically weak and cannot tolerate general anesthesia or surgery; (6) Those with serious bleeding tendency or coagulation disorders; (7) Patients who have been using anticoagulant or antiplatelet aggregating drugs for a long time, or those who have stopped using anticoagulant or antiplatelet aggregating drugs for less than 1 week before surgery (except for the prophylactic use of low molecular heparin before surgery); (8) Patients with active infectious diseases or other severe non-infectious infections; (9) Those who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (Hepatitis B) or Hepatitis C Surface Antigen (Hepatitis C).
• Hepatitis B Surface Antigen (HbsAg)-positive, Hepatitis C Virus (HCV)-positive, and syphilis-positive patients; (10) Persons with severe allergies, suspected or confirmed alcohol, drug or drug addiction; (11) Those with a history of epilepsy or psychosis or with cognitive impairment; (12) Women who are pregnant, breastfeeding, or planning to become pregnant during the trial, or male or female patients who do not wish to use barrier contraception during the trial; (13) Participation in any other clinical trial (except non-interventional trials) within 3 months prior to signing the informed consent form, planning to undergo any other major surgical procedure during the trial, or inability to recover from the side effects of a previous procedure; (14) Any other circumstances that the investigator considers inappropriate for participation in this clinical trial.

Sponsors & Collaborators

• Xuesong Li: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peking University First Hospital

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)