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Brain Awake Surgery Using Virtual Reality Headset (CERVO1)

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ClinicalTrials.gov Identifier: NCT03010943
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

Condition or disease Intervention/treatment Phase
Brain Tumor Virtual Reality Device: Virtual reality headset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brain surgery with virtual reality headset Device: Virtual reality headset
Feasibility and tolerance
Other Name: awake craniotomy




Primary Outcome Measures :
  1. percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset. [ Time Frame: During awake surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area

Exclusion Criteria:

  • Emergency
  • Any contra-indication to awake brain surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010943


Contacts
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Contact: Philippe Menei, MDPHD +33 2 41 35 48 22 phmenei@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49000
Contact: Philippe Menei, MDPHD    0241354822 ext +33    phmenei@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Study Director: Philippe MENEI, MDPHD University hospital of Angers

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03010943     History of Changes
Other Study ID Numbers: 2016-A01139-42
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Angers:
virtual reality
glioma surgery
awake craniotomy
brain tumor
glioma
neurosurgery

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases