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Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

NCT06324058 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-03-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Transurethral cryoablation

Using an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface.

PROCEDURE

Transurethral resection of bladder tumor

Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer

DRUG

Bcg Intravesical

Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Haowen Jiang, Pro. · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2025-03-18
Completion
2026-03-18

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324058 on ClinicalTrials.gov