Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

NCT ID: NCT00233350

Last Updated: 2015-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Brain Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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use of navigated 3D ultrasound during surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Supratentorial glioma

Exclusion Criteria

* Not willing to participate in study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geirmund Unsgaard, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan Normal University

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 20652608 (View on PubMed)

Other Identifiers

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Multicentre_3DUS

Identifier Type: -

Identifier Source: org_study_id

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