search
Back to results

Endoscopic-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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellopontine Angle Tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 18, 2017
    Last Updated
    July 21, 2017
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs