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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT06327932
Eligibility Criteria:
Inclusion Criteria:
1. Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).
2. Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).
3. KPS score ≥80, expected survival \> 30 months.
4. Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
5. Age between 18 and 70 years, all genders.
6. Volunteer to participate in this clinical trial and written informed consent.
Exclusion Criteria:
1. Patients with bladder cancer in situ.
2. Combined with proven upper urinary tract or urethral tumors.
3. The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
4. Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
5. Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy.
6. Patients with severe coagulation dysfunction.
7. A history of allergy to injected drugs (gemcitabine).
8. History of pelvic radiation, systemic chemotherapy, or immunotherapy.
9. Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases.
10. Patients with mental illness, substance abuse, alcoholism, and inability to cooperate.
11. Breastfeeding, pregnant, or planning to have a baby in the near future.
12. Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
13. Participated in other clinical trials 1 month before the trial.
14. Vesicoureteral regurgitation.
15. The investigator considered it inappropriate to participate in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06327932
Study Brief:
Protocol Section:
NCT06327932