Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

Brain Neoplasms Clinical Trial

Official title:

Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233350
• Other study ID #: Multicentre_3DUS
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: September 30, 2015
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Supratentorial glioma

Exclusion Criteria:

• Not willing to participate in study

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Device:
• use of navigated 3D ultrasound during surgery

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Solheim O, Selbekk T, Jakola AS, Unsgård 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. Epu — View Citation