- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181086
Pattern and Management of Intracranial Cavernoma
November 26, 2019 updated by: Moataz Elshenawi, Assiut University
Intracranial cavernous vascular malformations are variously known as cavernous angiomas, cavernous hemangiomas, or, more simply, cavernomas.
Cavernomas are congenital low flow vascular lesions.
It composed of irregular sinusoidal vascular channels, lacking smooth muscle, and elastic fibers.
They lack feeding arteries or draining veins and contain no neural tissue.
The first description of an intracranial cavernoma was given by Virchow, in 1863.
For over a century, it was considered to be an extremely rare malformation, usually found at autopsy, and exceptionally diagnosed during life.
The prevalence of cerebral cavernous malformations (CCM) is estimated to be 0.4-0.9%.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
35
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
all patients with confirmed diagnosis of intracranial cavernoma with MRI and will undergo surgery
Description
Inclusion Criteria:
- All patients presented with intracranial cavernomas (single or multiple, superficial or deep, supratentorial or infratentorial)
- Denovo or recurrent patients.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical outcome
Time Frame: one month post operative
|
Measured by Modified Rankin Scale Measures the degree of disability or dependence in the daily activities of people who have suffered any cause of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
|
one month post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
November 3, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
November 29, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2019
Last Update Submitted That Met QC Criteria
November 26, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- intracranial cavernoma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Management of Intracranial Cavernous Hemangioma
-
yuanli ZhaoPeking University International HospitalRecruitingEpilepsy | Seizures | Seizures, Epileptic | Cavernous Malformation, Cerebral | Cavernous Angioma | Cavernous Hemangioma | Cavernous Hemangioma of BrainChina
-
University of California, San FranciscoUniversity of Chicago; National Institute of Neurological Disorders and Stroke... and other collaboratorsRecruitingCerebral Cavernous Malformations | Cavernous Angioma, Familial | Cerebral Cavernous HemangiomaUnited States
-
University of New MexicoNational Institute of Neurological Disorders and Stroke (NINDS); University...TerminatedCerebral Cavernous Malformations | Cavernous Angioma, Familial | Cerebral Cavernous HemangiomaUnited States
-
Southwest Hospital, ChinaCompletedLaparoscopic Hepatectomy | Liver | Radio-frequency Ablation | Giant Cavernous HemangiomasChina
-
University of California, San FranciscoCompletedArteriovenous Malformations | Cavernous Angiomas | Brain AneurysmsUnited States
-
University of ChicagoJohns Hopkins University; Mayo Clinic; National Institute of Neurological Disorders... and other collaboratorsCompletedCerebral Cavernous Malformation | Cavernous Angioma | Cavernoma | CCM | Cerebral Cavernous Malformations 1 | Cerebral Cavernous Malformations 2 | Cerebral Cavernous Malformations 3United States
-
First Affiliated Hospital of Fujian Medical UniversityRecruitingCerebral Cavernous MalformationsChina
-
Seoul National University HospitalAsan Medical Center; Johannes Gutenberg University Mainz; Gyeongsang National... and other collaboratorsActive, not recruitingIntracerebral Hemorrhage | Cerebral Cavernous MalformationKorea, Republic of
-
University of VirginiaUnknownCavernous Malformations,Cerebral and/or SpinalUnited States
-
St. Joseph's Hospital and Medical Center, PhoenixTerminatedCerebral Cavernous MalformationsUnited States
Clinical Trials on surgical excision of intracranial cavernoma
-
University Hospital Inselspital, BerneCompleted
-
Sohag UniversityRecruitingSpinal Cord TumorEgypt
-
Kasr El Aini HospitalUnknownNeurocognitive Outcome Assesment in Patients With Perioptic Meningiomas
-
Lawson Health Research InstituteNot yet recruitingBreast Fibroadenoma | Lobular Carcinoma in Situ | Atypical Ductal Hyperplasia | Phyllodes Breast Tumor | Atypical Lobular Hyperplasia | Flat Epithelial Atypia | Phyllodes; Fibroadenoma | Radial Scar | Breast Papilloma | Complex Sclerosing Papillary Lesion of the Breast
-
Peking Union Medical College HospitalCompleted
-
Sohag UniversityActive, not recruiting
-
The Ottawa HospitalNot yet recruitingIntracranial Hemorrhages
-
Semmelweis UniversityRecruitingRecurrence | Periodontal; Lesion | Localized Gingival Enlargement | EpulidesHungary
-
Stanford UniversityRecruitingPilonidal DiseaseUnited States
-
Domain Surgical, Inc.Withdrawn