Cerebellopontine Angle TumorNCT03228511
Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
A study testing endoscope in people with Cerebellopontine Angle Tumor, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebellopontine Angle Tumor
- What is being tested?
- endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- meningeoma.
- vestibular schwannoma.
- arachnoid cyst.
- petroclival meningeoma.
Who cannot join
- trigeminal neuralgia.
- facial neuralgia.
About this study
Official title: Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
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
- Conditions
- Cerebellopontine Angle Tumor
- Being tested
- endoscope
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Formerly Arm Label | Experimental | Not described Receives: Device: endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellopontine Angle TumorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Tamam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228511
- Sponsor's protocol ID
- Easpost fossa
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
- ClinicalTrials.gov ID
- NCT03228511
- Acronym / sponsor ID
- Easpost fossa
- Conditions
- Cerebellopontine Angle Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formerly Arm Label | Experimental | Device: endoscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- meningeoma.
- vestibular schwannoma.
- arachnoid cyst.
- petroclival meningeoma.
Key exclusion criteria (2 listed)
- trigeminal neuralgia.
- facial neuralgia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopeIt is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions | Device | Formerly Arm Label |
Primary outcome
post operative residual tumor
Time frame: 1 week
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing endoscope in people with Cerebellopontine Angle Tumor, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative residual tumor (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.