Carcinoma of Urinary Bladder, Invasive Clinical Trial
Official title:
An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral
Resection - TUR), followed by series of intravesical instillations of prophylactic
chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid
dilution the chemotheraputic drug by the incoming urine and clearance by urination.
TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable
gel (TC-3)for MMC retention in the urinary bladder.
Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed
with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder,
the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine
the gel dissolves and is cleared out from the bladder.
Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to
prolongation of treatment duration and consequently improving bladder exposure to MMC.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label