Prevalence of Anatomical Variants of Dural Sinuses by MRV... | NCT06120010

Studies
Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag

NCT06120010

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

169Estimated

Phase

Not provided

Conditions

Anatomical Variants of Dural Sinuses by MRV

Interventions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Oct 24, 2023

First Submission Date that Met QC Criteria

Nov 5, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2023

Last Update Posted Date

Nov 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marina Makram Sabah, Resident-Diagnostic and interventional Radiology department, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

169Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	To detect prevalence of anatomical variants of dural sinuses by MRV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of anatomical variants of dural sinuses in Sohag population	Number of anatomical variants of dural sinuses by MRV evaluation in Sohag	8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Exclusion Criteria:

Having the diagnosis of cerebral venous sinus thrombosis, congential or acquired intracranial abnormalities, ischemic or hemorrhagic stroke, intracranial hypertension, intracranial space occuping lesion, and previous head injury or neurosurgery, also patients with absolute or relative contraindications for imaging including claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marina M Sabah, resident	Contact	01201796003		marinamakram@med.sohag.edu.eg
Mohamed Th Mahmoud, professor	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university Hospital	Recruiting	Sohag		Sohag	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32220779	Background	van Dam LF, van Walderveen MAA, Kroft LJM, Kruyt ND, Wermer MJH, van Osch MJP, Huisman MV, Klok FA. Current imaging modalities for diagnosing cerebral vein thrombosis - A critical review. Thromb Res. 2020 May;189:132-139. doi: 10.1016/j.thromres.2020.03.011. Epub 2020 Mar 19.
17050515	Background	Leach JL, Fortuna RB, Jones BV, Gaskill-Shipley MF. Imaging of cerebral venous thrombosis: current techniques, spectrum of findings, and diagnostic pitfalls. Radiographics. 2006 Oct;26 Suppl 1:S19-41; discussion S42-3. doi: 10.1148/rg.26si055174.