A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

NCT02296580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-02-02

No results posted yet for this study

Summary

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.

Conditions

Interventions

DEVICE

Nativis Voyager RFE Therapy

Nativis Voyager Radiofrequency Energy Therapy

Sponsors & Collaborators

  • Nativis, Inc.

    lead INDUSTRY

Principal Investigators

  • Donna Morgan Murray, PhD · Nativis, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2021-09-30
Completion
2021-09-30
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

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 NCT02296580 on ClinicalTrials.gov