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Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC

NCT01803295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-16

No results posted yet for this study

Summary

In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode

The investigators believe that this study is of importance of several aspects:

1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
2. If proved effective this mode of treatment might save the need of TURBT performance and serve as a new mode of tumor ablation.
3. Even if proved partially effective this mode of treatment will diminish tumors size or number thus enable a more limited TURBT procedure.
4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT, which might improve the patient's prognostic outcome.
5. If this experimental treatment will prove to have a better ablative effect, this could be translated to a better prophylactic effect of tumor recurrence.

Conditions

  • Carcinoma of Urinary Bladder, Superficial

Interventions

DEVICE

40 mg MMC gel

A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder.

OTHER

Standard of care MMC mixed with water

Standard of care 40mg MMC mixed with water

DEVICE

80 mg MMC gel

A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Fred Witjes, Prof · Radboud University Nijmegen Medical Centre, Department of Urology Geert Grooteplein South 10 (659), Nijmegen

  • Stenzl, Prof. · Tübingen Universitätsklinik für Urologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-07-31
Completion
2017-06-30

Countries

  • Israel
  • Italy
  • Spain
  • Switzerland

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 NCT01803295 on ClinicalTrials.gov