New Thyroid Fine Needle Aspiration Biopsy Apparatus | NCT01512212

Studies
New Thyroid Fine Needle Aspiration Biopsy Apparatus

NCT01512212

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

Jan 19, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Thyroid Cancer

Interventions

biopsy

Countries

Turkey (Türkiye)

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

Jan 2012

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

Jan 2012

Primary Completion Date

Jun 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jan 10, 2012

First Submission Date that Met QC Criteria

Jan 13, 2012

First Posted Date

Jan 19, 2012Estimated

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

Jan 13, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erhan Aysan, MD Prof., SB Istanbul Education and Research HospitalPrincipal Investigator

Lead Sponsor

SB Istanbul Education and Research HospitalOTHER

Collaborators

Name	Class
Bezmialem Vakif University	OTHER

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

Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB) apparatus of which patented from Turkish Patent Institute.

Detailed Description

The author group of this investigation produced a new thyroid fine needle aspiration biopsy (FNAB) apparatus and patented it from Turkish patent Institute. FNAB indicated nodular goitre patients are the subjects of this research. First, the investigators will perform standart FNAB after this procedure will perform FNAB with new apparatus. The investigators will evaluate the aspirates according to number of cells and malignity ratio of cells.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single group	No Intervention	FNAB will be perform first with standart technique and after with new FNAB apparatus	Procedure: biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biopsy	Procedure	fnab	single group	fnab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of cells	number of aspirated cells will be compared	2

Secondary Outcomes

Measure	Description	Time Frame
type of cells	type (benign, suspect, malign) of cells will be compared	2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fine needle aspiration biopsy indicated noduler goiter patients

Exclusion Criteria:

diffuse goiter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
erhan aysan, prof	Contact	902122531700		dr@webcerrah.com
adnan yuksel, prof	Contact	902124531701		ayuksel@bezmialem.edu.tr

Overall Officials

Name	Affiliation	Role
adnan yuksel, prof	Bezmialem Vakif University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University	Recruiting	Istanbul	Marmara	34564	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy
C492759	1-fluoro-2-nitro-4-azidobenzene

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided