A Feasibility Study of the Nativis Voyager® System in Pat... | NCT02507102

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

NCT02507102

Sponsor

Nativis, Inc.

Status

Completed

Last Update Posted

Mar 30, 2018Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Glioblastoma Multiforme

Interventions

Voyager

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Mar 26, 2018Actual

First Submitted Date

Jul 22, 2015

First Submission Date that Met QC Criteria

Jul 22, 2015

First Posted Date

Jul 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Voyager Therapy	Experimental	Investigational treatment with Voyager Therapy	Device: Voyager

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voyager	Device	Non-invasive RFE therapy	Investigational Voyager Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System		6 months
Tumor Response	Tumor imaging response (RANO) at two months of therapy.	2 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival at six months compared with historical response		6 months
Progression free survival		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 progressive disease with 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.
Subject has provided signed informed consent.

Exclusion Criteria:

Subject has life expectancy less than eight weeks
Subject has received other investigational therapy within the last 28 days.
Subject has received surgery within the last two weeks or not fully from prior surgery.
Subject has a clinically significant electrolyte abnormality.
Subject has an active implantable (e.g., neurostimulator, pacemaker) 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 study period.
Subject is participating in other investigational research.
Subject has any condition that at the discretion of the investigator would preclude participation in the study.
Subject is unable or unwilling to comply with the protocol-required follow-up schedule.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors