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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04181086
Other study ID # intracranial cavernoma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2022

Study information

Verified date November 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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%.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date January 1, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Hemangioma
  • Management of Intracranial Cavernous Hemangioma

Intervention

Procedure:
surgical excision of intracranial cavernoma
microvascular excision of intracranial cavernoma

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary clinical outcome 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.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
one month post operative