Application of the Sentire C1000 for Ureteral Stricture Repair

Launched by XUESONG LI · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical system called the Sten® Laparoendoscopic Surgical System C1000, which is being evaluated for its safety and effectiveness in repairing ureteral strictures, a condition where the ureter becomes narrowed, often leading to urinary problems. The trial aims to enroll 50 patients aged between 18 and 80 who need surgery to repair their upper urinary tract. To participate, individuals must be suitable for this type of surgery and willingly agree to take part in the study after being informed about the process and any potential risks.

Participants in the trial can expect to undergo surgery using the new system and will be monitored for various outcomes, including how well the surgery works, the time it takes, any pain they experience afterward, and their overall recovery. The study is expected to last about 9 months, with 6 months dedicated to enrolling patients and 3 months for follow-up care. It's important to note that certain individuals, such as those with specific health conditions or allergies, may not be eligible to participate. Overall, this trial aims to gather important information that could improve future treatments for ureteral strictures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (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.
• Exclusion Criteria:
• • (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.