Actively Recruiting
Application of the Sentire C1000 for Ureteral Stricture Repair
Led by Xuesong Li · Updated on 2025-05-21
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Application of the Sentire C1000 for Ureteral Stricture Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years, male or female
- Patients who need to undergo upper urinary tract repair surgery
- Patients suitable for ureteral reconstruction surgery as confirmed by the investigator
- Patients who voluntarily agree to participate and sign the informed consent form
- Willingness to cooperate and complete trial follow-up and related examinations
You will not qualify if you...
- Severe allergy to drugs or imaging contrast agents
- History of pelvic or abdominal surgery with severe adhesions
- History of other malignancies deemed unsuitable by the investigator
- Diseases preventing pneumoperitoneum or certain surgical positioning (e.g., spinal deformity, ankylosing spondylitis)
- Serious comorbidities or physical weakness preventing general anesthesia or surgery
- Serious bleeding disorders or coagulation problems
- Long-term use of anticoagulant or antiplatelet drugs, or stopped less than 1 week before surgery (except prophylactic low molecular heparin)
- Active infectious or severe non-infectious diseases
- Positive for HIV, Hepatitis B surface antigen, or Hepatitis C surface antigen
- Severe allergies, or suspected/confirmed alcohol or drug addiction
- History of epilepsy, psychosis, or cognitive impairment
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial, or patients unwilling to use barrier contraception
- Participation in other clinical trials within 3 months before consent, planned major surgery during the trial, or unresolved side effects from prior procedures
- Any other conditions the investigator judges as unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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