Cerebral, Meningeal Biopsy by Flexible Endoscopy in Patie... | NCT01073280

Studies
Cerebral, Meningeal Biopsy by Flexible Endoscopy in Patients Without Neurological Diagnosis

NCT01073280

Sponsor

Universidad Autonoma de San Luis Potosí

Status

Unknown status

Last Update Posted

Feb 23, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Neurological Disease

Interventions

cerebral flexible endoscopy

Countries

Mexico

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

Feb 2010

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

Nov 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Feb 22, 2010

First Submission Date that Met QC Criteria

Feb 22, 2010

First Posted Date

Feb 23, 2010Estimated

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

Feb 22, 2010

Last Update Posted Date

Feb 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigators will take cerebral and subarachnoid biopsy by flexible endoscopy in patients without neurological findings. The investigators will use retrospective and prospective patients.

Detailed Description

Test the useful of the flexible endoscopy in patients without neurological diagnosis.

Developed a diagnosis method for idiopathic neurological findings.

Compare the cerebral and subarachnoid biopsy each other

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
undeterminated neurological disease, cerebral endoscopy		patients without neurological diagnosis that require cerebral , meningeal diagnosis	Procedure: cerebral flexible endoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cerebral flexible endoscopy	Procedure	The investigators will make a burrhole in the precoronal suture introducing the flexible endoscope taking a cerebral and a basal meningeal biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test the useful of the cerebral and subarachnoid biopsy by flexible endoscopy in patients without neurological findings		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Developed a diagnosis method for idiopathic neurological findings. Compare the cerebral and subarachnoid biopsy each other		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with neurological disease and with out diagnosis

Exclusion Criteria:

death of the patient
patients with neurological diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients between 0 and 85years old with neurological diseases that there are not a diagnosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jesus Martin Sanchez Aguilar, surgeon	Contact			jemarsan7@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Central Dr. Ignacio Morones Prieto	Recruiting	San Luis Potosí City	San Luis Potosí	78210	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D009422	Nervous System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided