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Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC - Trial NCT06324058

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.

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NCT06324058
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Trial Details
ClinicalTrials.gov โ€ข NCT06324058
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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

Study Focus

Bladder Cancer

Transurethral cryoablation

Interventional

procedure

Sponsor & Location

Huashan Hospital

Timeline & Enrollment

N/A

Mar 18, 2024

Mar 18, 2026

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 bladder
Malignant neoplasm: Bladder, unspecified
Malignant neoplasm: Dome of bladder
Malignant neoplasm: Overlapping lesion of bladder
Malignant neoplasm: Lateral wall of bladder

Data Source

ClinicalTrials.gov

NCT06324058

Non-Device Trial