{
  "FullStudy":{
    "Rank":218140,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512212",
          "OrgStudyIdInfo":{
            "OrgStudyId":"thyroid.iiab"
          },
          "Organization":{
            "OrgFullName":"SB Istanbul Education and Research Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"New Thyroid Fine Needle Aspiration Biopsy Apparatus",
          "OfficialTitle":"New Thyroid Fine Needle Biopsy Apparatus",
          "Acronym":"fnab"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Erhan Aysan",
            "ResponsiblePartyInvestigatorTitle":"MD Prof.",
            "ResponsiblePartyInvestigatorAffiliation":"SB Istanbul Education and Research Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"SB Istanbul Education and Research Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Bezmialem Vakif University",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB) apparatus of which patented from Turkish Patent Institute.",
          "DetailedDescription":"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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Thyroid Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "thyroid",
              "fine",
              "needle",
              "aspiration",
              "biopsy",
              "new",
              "technique"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"single group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"FNAB will be perform first with standart technique and after with new FNAB apparatus",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: biopsy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"biopsy",
                "InterventionDescription":"fnab",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "single group"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "fnab"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"number of cells",
                "PrimaryOutcomeDescription":"number of aspirated cells will be compared",
                "PrimaryOutcomeTimeFrame":"2"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"type of cells",
                "SecondaryOutcomeDescription":"type (benign, suspect, malign) of cells will be compared",
                "SecondaryOutcomeTimeFrame":"2"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nfine needle aspiration biopsy indicated noduler goiter patients\n\nExclusion Criteria:\n\ndiffuse goiter",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"17 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"erhan aysan, prof",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"902122531700",
                "CentralContactEMail":"dr@webcerrah.com"
              },{
                "CentralContactName":"adnan yuksel, prof",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"902124531701",
                "CentralContactEMail":"ayuksel@bezmialem.edu.tr"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"adnan yuksel, prof",
                "OverallOfficialAffiliation":"Bezmialem Vakif University",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Bezmialem Vakif University",
                "LocationStatus":"Recruiting",
                "LocationCity":"Istanbul",
                "LocationState":"Marmara",
                "LocationZip":"34564",
                "LocationCountry":"Turkey",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"erhan aysan, prof",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"2124531700",
                      "LocationContactEMail":"dr@webcerrah.com"
                    },{
                      "LocationContactName":"adnan yuksel, prof",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"902124531701",
                      "LocationContactEMail":"ayuksel@bezmialem.edu.tr"
                    },{
                      "LocationContactName":"erhan aysan, prof",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"yeliz ersoy, md",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013964",
                "ConditionMeshTerm":"Thyroid Neoplasms"
              },{
                "ConditionMeshId":"D000013959",
                "ConditionMeshTerm":"Thyroid Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              },{
                "ConditionAncestorId":"D000004701",
                "ConditionAncestorTerm":"Endocrine Gland Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000006258",
                "ConditionAncestorTerm":"Head and Neck Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M15306",
                "ConditionBrowseLeafName":"Thyroid Neoplasms",
                "ConditionBrowseLeafAsFound":"Thyroid Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15301",
                "ConditionBrowseLeafName":"Thyroid Diseases",
                "ConditionBrowseLeafAsFound":"Thyroid",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6446",
                "ConditionBrowseLeafName":"Endocrine Gland Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7931",
                "ConditionBrowseLeafName":"Head and Neck Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}