NCT03228511

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 :

  1. 1.Intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction.
  2. 2.Post-operative tumor control confirmed comparison between pre and postoperative MRI.
  3. 3.Postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

3.4 years

First QC Date

July 18, 2017

Last Update Submit

July 21, 2017

Conditions

Cerebellopontine Angle Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

    1 week

Study Arms (1)

Formerly Arm Label

EXPERIMENTAL
Device: endoscope

Interventions

endoscopeDEVICE

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

Formerly Arm Label

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • meningeoma.
  • vestibular schwannoma.
  • arachnoid cyst.
  • petroclival meningeoma.

You may not qualify if:

  • trigeminal neuralgia.
  • facial neuralgia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invistigator

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 25, 2017

Study Start

August 1, 2017

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

July 25, 2017

Record last verified: 2017-07