MedTrace Logo

Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer

NCT01648010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2013-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma of Urinary Bladder, Invasive

Interventions

DEVICE

TC-3 gel

One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.

DEVICE

TC-3 gel mixed with Mitomycin C (MMC)

One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Michal Jeshurun, MD · UroGen Pharma Ltd.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01648010 on ClinicalTrials.gov