{
  "FullStudy":{
    "Rank":217889,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515514",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-006327"
          },
          "Organization":{
            "OrgFullName":"Mayo Clinic",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Confocal Endomicroscopy for GI Neoplasia Study",
          "OfficialTitle":"Confocal Endomicroscopy for GI Neoplasia Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 15, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 17, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Michael Wallace",
            "ResponsiblePartyInvestigatorTitle":"Primary Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Mayo Clinic"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Mayo Clinic",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Bankhead-Coley",
                "CollaboratorClass":"UNKNOWN"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard \"free-hand\" image acquisition.",
          "DetailedDescription":"The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colorectal Polyps"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "polyps",
              "inflammatory bowel disease",
              "associated neoplasia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Quality of the confocal image",
                "PrimaryOutcomeDescription":"Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.",
                "PrimaryOutcomeTimeFrame":"1 yr"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nThose patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.\n\nExclusion Criteria:\n\nPatients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Approximately 40 patients with polyps",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Michael B Wallace, MD,MPH",
                "OverallOfficialAffiliation":"Mayo Clinic",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Mayo Clinic Florida",
                "LocationCity":"Jacksonville",
                "LocationState":"Florida",
                "LocationZip":"32224",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009369",
                "ConditionMeshTerm":"Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M7469",
                "ConditionBrowseLeafName":"Gastrointestinal Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12594",
                "ConditionBrowseLeafName":"Polyps",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16500",
                "ConditionBrowseLeafName":"Inflammatory Bowel Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5839",
                "ConditionBrowseLeafName":"Digestive System Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}