Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT06983067
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06983067
Study Brief:
Protocol Section:
NCT06983067