Back to resultsEndoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
Primary Purpose
Cerebellopontine Angle Tumor
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endoscope
Sponsored by
About this trial
This is an interventional treatment trial for Cerebellopontine Angle Tumor
Eligibility Criteria
Inclusion Criteria: cerebellopontine angle lesions
- meningeoma.
- vestibular schwannoma.
- arachnoid cyst.
- petroclival meningeoma.
Exclusion Criteria:
- trigeminal neuralgia.
- facial neuralgia.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Formerly Arm Label
Arm Description
Outcomes
Primary Outcome Measures
post operative residual tumor
post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228511
Brief Title
Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
Official Title
Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to estimate the following :
Intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction.
Post-operative tumor control confirmed comparison between pre and postoperative MRI.
Postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellopontine Angle Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formerly Arm Label
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
endoscope
Intervention Description
It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions
Primary Outcome Measure Information:
Title
post operative residual tumor
Description
post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cerebellopontine angle lesions
meningeoma.
vestibular schwannoma.
arachnoid cyst.
petroclival meningeoma.
Exclusion Criteria:
trigeminal neuralgia.
facial neuralgia.
12. IPD Sharing Statement
Learn more about this trial
Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
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