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New Thyroid Fine Needle Aspiration Biopsy Apparatus (fnab)

Primary Purpose

Thyroid Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
biopsy
Sponsored by
SB Istanbul Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Cancer focused on measuring thyroid, fine, needle, aspiration, biopsy, new, technique

Eligibility Criteria

17 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • fine needle aspiration biopsy indicated noduler goiter patients

Exclusion Criteria:

  • diffuse goiter

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

single group

Arm Description

FNAB will be perform first with standart technique and after with new FNAB apparatus

Outcomes

Primary Outcome Measures

number of cells
number of aspirated cells will be compared

Secondary Outcome Measures

type of cells
type (benign, suspect, malign) of cells will be compared

Full Information

First Posted
January 10, 2012
Last Updated
January 13, 2012
Sponsor
SB Istanbul Education and Research Hospital
Collaborators
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT01512212
Brief Title
New Thyroid Fine Needle Aspiration Biopsy Apparatus
Acronym
fnab
Official Title
New Thyroid Fine Needle Biopsy Apparatus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SB Istanbul Education and Research Hospital
Collaborators
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
thyroid, fine, needle, aspiration, biopsy, new, technique

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
No Intervention
Arm Description
FNAB will be perform first with standart technique and after with new FNAB apparatus
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
fnab
Intervention Description
fnab
Primary Outcome Measure Information:
Title
number of cells
Description
number of aspirated cells will be compared
Time Frame
2
Secondary Outcome Measure Information:
Title
type of cells
Description
type (benign, suspect, malign) of cells will be compared
Time Frame
2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: fine needle aspiration biopsy indicated noduler goiter patients Exclusion Criteria: diffuse goiter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
erhan aysan, prof
Phone
902122531700
Email
dr@webcerrah.com
First Name & Middle Initial & Last Name or Official Title & Degree
adnan yuksel, prof
Phone
902124531701
Email
ayuksel@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
adnan yuksel, prof
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
34564
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
erhan aysan, prof
Phone
2124531700
Email
dr@webcerrah.com
First Name & Middle Initial & Last Name & Degree
adnan yuksel, prof
Phone
902124531701
Email
ayuksel@bezmialem.edu.tr
First Name & Middle Initial & Last Name & Degree
erhan aysan, prof
First Name & Middle Initial & Last Name & Degree
yeliz ersoy, md

12. IPD Sharing Statement

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New Thyroid Fine Needle Aspiration Biopsy Apparatus

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