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SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

NCT02254915 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-01

No results posted yet for this study

Summary

A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.

Conditions

  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Urinary Bladder Diseases
  • Urologic Diseases

Interventions

DEVICE

Synergo + MMC

Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.

DRUG

Bacillus Calmette-Guérin

Intravesical instillation of BCG.

Sponsors & Collaborators

  • Medical Enterprises Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Igal Ruvinsky, PhD · Medical Enterprises Europe B.V.

  • Gerson Luedecke, Dr. med. · Universitätsklinikum Gießen und Marburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2020-01-31

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Drugs

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 NCT02254915 on ClinicalTrials.gov