New Thyroid Fine Needle Aspiration Biopsy Apparatus (fnab)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by SB Istanbul Education and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bezmialem Vakif University
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01512212
First received: January 10, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Thyroid Cancer
Procedure: biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: New Thyroid Fine Needle Biopsy Apparatus

Resource links provided by NLM:


Further study details as provided by SB Istanbul Education and Research Hospital:

Primary Outcome Measures:
  • number of cells [ Time Frame: 2 ] [ Designated as safety issue: No ]
    number of aspirated cells will be compared


Secondary Outcome Measures:
  • type of cells [ Time Frame: 2 ] [ Designated as safety issue: No ]
    type (benign, suspect, malign) of cells will be compared


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: single group
FNAB will be perform first with standart technique and after with new FNAB apparatus
Procedure: biopsy
fnab
Other Name: fnab

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.

  Eligibility

Ages Eligible for Study:   17 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fine needle aspiration biopsy indicated noduler goiter patients

Exclusion Criteria:

  • diffuse goiter
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512212

Contacts
Contact: erhan aysan, prof 902122531700 dr@webcerrah.com
Contact: adnan yuksel, prof 902124531701 ayuksel@bezmialem.edu.tr

Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Marmara, Turkey, 34564
Contact: erhan aysan, prof    2124531700    dr@webcerrah.com   
Contact: adnan yuksel, prof    902124531701    ayuksel@bezmialem.edu.tr   
Principal Investigator: erhan aysan, prof         
Sub-Investigator: yeliz ersoy, md         
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Bezmialem Vakif University
Investigators
Study Chair: adnan yuksel, prof Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Erhan Aysan, MD Prof., SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01512212     History of Changes
Other Study ID Numbers: thyroid.iiab
Study First Received: January 10, 2012
Last Updated: January 13, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by SB Istanbul Education and Research Hospital:
thyroid
fine
needle
aspiration
biopsy
new
technique

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014