drugset
drugset / Trial / NCT04671407

The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer

NCT04671407 ↗

Phase 2 Unknown 150 enrolled Kaplan Medical Center
RandomizedParallel-groupTriple-blindPrevention

Summary

Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT. Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects. Patients A total of 150 patients will be enrolled in this trial.

Timeline

Start
2021-01-20
Primary completion
2022-12-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hypertonic saline Unknown 40 ml Other

Indications

No indication recorded.