Clinical Evaluation of Navigated 3D Ultrasound Multicentr... | NCT00233350

Studies
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

NCT00233350

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Oct 1, 2015Estimated

Enrollment

142Actual

Phase

Not provided

Conditions

Brain Neoplasms

Interventions

use of navigated 3D ultrasound during surgery

Countries

Norway

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

Oct 2012

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

Jan 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 4, 2005

First Posted Date

Oct 5, 2005Estimated

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

Sep 30, 2015

Last Update Posted Date

Oct 1, 2015Estimated

Name	Class
St. Olavs Hospital	OTHER

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

3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

Detailed Description

The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Name	Type	Description	Arm Group Labels	Other Names
use of navigated 3D ultrasound during surgery	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Supratentorial glioma

Exclusion Criteria:

Not willing to participate in study

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

All patients who were operated for intracranial high-grade gliomas (World Health Organisation(WHO) grade III/IV) in the 3-year period between January 1st 2007 and December 31st 2009 in the Department of Neurosurgery, St. Olavs University Hospital, Trondheim, Norway

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geirmund Unsgaard, MD, PhD	National Taiwan Normal University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs Hospital		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20652608	Result	Solheim O, Selbekk T, Jakola AS, Unsgard G. Ultrasound-guided operations in unselected high-grade gliomas--overall results, impact of image quality and patient selection. Acta Neurochir (Wien). 2010 Nov;152(11):1873-86. doi: 10.1007/s00701-010-0731-5. Epub 2010 Jul 21.

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms