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RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)

NCT02471495 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-05-07

No results posted yet for this study

Summary

This multicenter, prospective, single-arm, phase 3 study will assess the proportion of disease-free patients, starting from administration of the first study treatment to at least 12-months after the first treatment, and up to 2 years (the latter only in patients choosing to participate in longer-term disease-free-survival data collection).

Conditions

Interventions

DEVICE

Synergo® RITE + MMC

Synergo® system delivers homogenous microwave hyperthermia to the bladder wall in combination with bladder instillation of cold chemotherapeutic agent - Mitomycin C (MMC).The energy-delivering unit and the intravesical irrigation system are computer-controlled, The irrigation system consists of a disposable tubing line and catheter set. The catheter is a triple-lumen, silicone, transurethral Foley-type catheter. MMC is constituted as a powder (40 mg) dissolved in 50 ml sterile water for injection.

Sponsors & Collaborators

  • Medical Enterprises Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Igal Ruvinsky, PhD · Medical Enterprises

  • Shariat Shahrokh, Prof. med · Medical University Vienna, General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-01-31
Completion
2020-01-31

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Entities

Diseases

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 NCT02471495 on ClinicalTrials.gov