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Hypertonic Saline for NMIBC Recurrence Prevention
NCT04671407Phase 2
Key facts
- Status
- Unknown
- Start
- Jan 2021
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Kaplan Medical Center
- Modality
- Small Molecules, Device-based Delivery
- Drugs
- hypertonic saline
- Conditions
- Non-muscle-invasive bladder cancer (NMIBC)
01
Overview
Phase 2, randomised, double-blind trial of hypertonic saline in Non-muscle-invasive bladder cancer (NMIBC) (2 arms), sponsored by Kaplan Medical Center. Primary endpoint: Tumor Recurrence Rate at 24 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hypertonic Saline
40ml of Hypertonic Saline (3% NaCl)
Normal Saline
40ml of Normal Saline (0.9% NaCl)
03
Who it enrols
Newly diagnosed papillary bladder tumors < 3cm, normal upper tracts, no prior urothelial carcinoma, normal renal function and sodium levels.
04
Endpoints
Primary
Tumor Recurrence Rate
Secondary
Time to Recurrence
Side Effects
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