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NCT06324058Not yet recruiting

Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
Huashan HospitalClinicalTrials.govprocedure
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
Transurethral cryoablation
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Huashan Hospital
Timeline & enrollment
Phase
N/A
Start date
Mar 18, 2024
End date
Mar 18, 2026
Enrollment
190 participants
Primary outcome

Tumor residual rate

Summary

This trial plans to enroll 190 eligible patients and randomize them into two groups with a
 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate
 cryoablation therapy at the resection site after TUR, while the control group will only
 undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of
 subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the
 tumor-free residual rates and adverse events between the two groups.

ICD-10 classifications
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06324058
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06324058 through Pure Global AI's free database. This phase not specified trial is sponsored by Huashan Hospital and is currently Not yet recruiting. The study focuses on Bladder Cancer. Target enrollment is 190 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.