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HUMC 1612: Optune NovoTTF-200A System

NCT03128047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-07-08

Study results available
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Summary

The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.

Conditions

Interventions

DEVICE

Optune NovoTTF-200A System

Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Derek Hanson, MD · Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2024-07-08
Completion
2025-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03128047 on ClinicalTrials.gov