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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 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

  • TCC

Interventions

DRUG

Hypertonic Saline

Hypertonic Saline 3% and 0.9%

Sponsors & Collaborators

  • Kaplan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

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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 NCT04671407 on ClinicalTrials.gov