Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Kashani Social Security Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kashani Social Security Hospital
ClinicalTrials.gov Identifier:
NCT00595660
First received: January 7, 2008
Last updated: January 15, 2008
Last verified: January 2008
  Purpose

Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.


Condition Intervention
Palpable Breast Mass
Procedure: FNA - fine needle aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

Further study details as provided by Kashani Social Security Hospital:

Primary Outcome Measures:
  • specimen adequacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Needle 21 for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 2
22 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 3
23 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 4
24 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration

Detailed Description:

Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any Woman with palpable Breast Mass

Exclusion Criteria:

  • Previous open Biopsy or Surgery
  • Active infection
  • Breast cysts
  • Patient refusal to do FNA
  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: NCT00595660

Contacts
Contact: Bijan -- Mohammadhosseini, General Surgeon,MD +989121009677 ext --- bijanmh@Gmail.com

Locations
Iran, Islamic Republic of
Kashani Social Security Hospital Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Bijan Mohammadhosseini, General Surgeon,MD    +989121009677    bijanmh@Gmail.com   
Sponsors and Collaborators
Kashani Social Security Hospital
Investigators
Principal Investigator: Bijan Mohammadhosseini, General Surgeon,MD Kashani Social Security Hospital
  More Information

No publications provided

Responsible Party: Dr.Hamidzadeh, Kashani Social Security Hospital
ClinicalTrials.gov Identifier: NCT00595660     History of Changes
Other Study ID Numbers: 17251-10/10/1386
Study First Received: January 7, 2008
Last Updated: January 15, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Kashani Social Security Hospital:
Palpable Breast Mass
FNA
Cytology
Fine needle aspiration
Specimen Adequacy

ClinicalTrials.gov processed this record on August 28, 2014