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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Nativis, Inc.
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.
ClinicalTrials.gov Identifier:
NCT02296580
First received: November 18, 2014
Last updated: April 17, 2017
Last verified: April 2017
November 18, 2014
April 17, 2017
December 2014
June 2017   (Final data collection date for primary outcome measure)
  • Number of any adverse events associated with the investigational therapy. [ Time Frame: 6 months ]
  • Progression-free Survival (PFS) [ Time Frame: 6 months ]
  • Number of any adverse events associated with the investigational therapy. [ Time Frame: 6 months ]
  • Tumor Progression [ Time Frame: Two months ]
    Radiological response of the tumor will be assessed by MRI studies according to RANO
Complete list of historical versions of study NCT02296580 on ClinicalTrials.gov Archive Site
  • Tumor Progression [ Time Frame: Two months ]
    Radiological response of the tumor will be assessed by MRI studies according to RANO
  • Overall Survival [ Time Frame: 6 months ]
Overall survival and progression free survival [ Time Frame: six months ]
Not Provided
Not Provided
 
A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)
A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)
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 64 subjects of which 32 will be treated with the Voyager therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy. Safety and clinical utility will be evaluated.
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 64 subjects of which 32 will be treated with the Voyager therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy. Safety and clinical utility will be evaluated.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Glioblastoma Multiforme
Device: Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Experimental: Nativis Voyager RFE Therapy
Subjects will be treated with Nativis Voyager therapy for up to six months.
Intervention: Device: Nativis Voyager RFE Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2017
June 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has histologically confirmed diagnosis of GBM.
  • Subject has failed or intolerant to radiotherapy.
  • Subjects has failed or intolerant to temozolomide therapy.
  • Subject has at least one measureable lesion on MRI or CT.
  • Subject is at least 18 years of age.
  • Subject has a KPS ≥ 60.
  • Subject has adequate organ and marrow function.

Exclusion Criteria:

  • Subject is currently being treated with other investigational agents.
  • Subject has received other investigational therapy within the last 28 days.
  • Subject has received surgery within the last four weeks.
  • Subject has a clinically significant electrolyte abnormality.
  • Subject has an active implantable or other electromagnetic device.
  • Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
  • Subject is known to be HIV positive.
  • Subject is pregnant, nursing or intends to become pregnant during the course of the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Char Bame, BSN MBA 206-775-5436 cbame@nativis.com
United States
 
 
NCT02296580
NAT-101
No
Not Provided
Not Provided
Not Provided
Nativis, Inc.
Nativis, Inc.
Not Provided
Not Provided
Nativis, Inc.
April 2017

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