Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507102
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE July 23, 2015
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System [ Time Frame: 6 months ]
  • Tumor Response [ Time Frame: 2 months ]
    Tumor imaging response (RANO) at two months of therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Overall survival at six months compared with historical response [ Time Frame: 6 months ]
  • Progression free survival [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Official Title  ICMJE A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Brief Summary This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE Device: Voyager
Non-invasive RFE therapy
Study Arms  ICMJE Experimental: Investigational Voyager Therapy
Investigational treatment with Voyager Therapy
Intervention: Device: Voyager
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2015)
11
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 26, 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has histologically confirmed diagnosis of GBM.
  2. Subject has failed or intolerant to radiotherapy.
  3. Subjects has failed or intolerant to temozolomide therapy.
  4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
  5. Subject is at least 18 years of age.
  6. Subject has a KPS ≥ 60.
  7. Subject has adequate organ and marrow function.
  8. Subject has provided signed informed consent.

Exclusion Criteria:

  1. Subject has life expectancy less than eight weeks
  2. Subject has received other investigational therapy within the last 28 days.
  3. Subject has received surgery within the last two weeks or not fully from prior surgery.
  4. Subject has a clinically significant electrolyte abnormality.
  5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
  6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
  7. Subject is known to be HIV positive.
  8. Subject is pregnant, nursing or intends to become pregnant during the study period.
  9. Subject is participating in other investigational research.
  10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
  11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02507102
Other Study ID Numbers  ICMJE NAT-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nativis, Inc.
Study Sponsor  ICMJE Nativis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donna Morgan Murray, PhD Nativis, Inc.
PRS Account Nativis, Inc.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP