{
  "FullStudy":{
    "Rank":217608,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519180",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2010/148/HP"
          },
          "Organization":{
            "OrgFullName":"University Hospital, Rouen",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis",
          "OfficialTitle":"Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 5, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 8, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital, Rouen",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.",
          "DetailedDescription":"The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Gastroparesis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "gastroparesis",
              "gastric emptying",
              "antro-duodenal manometry"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"32",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control group",
                "ArmGroupDescription":"Healthy volunteers"
              },{
                "ArmGroupLabel":"Idiopathic gastroparesis",
                "ArmGroupDescription":"Idiopathic gastroparesis"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"antro-pyloro-duodenal pressure",
                "PrimaryOutcomeDescription":"the main outcome is the pressure measured using pressure sensors within the antrum, the pylorus, and the first part of the duodenum. This will be measured during 3h fast. Pressures measured in the antrum, the pylorus, and the duodenum wiil be compared between healthy volunteers and gastroparetic patients",
                "PrimaryOutcomeTimeFrame":"3h"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nIdiopathic gastroparesis or healthy volunteers\nIdiopathic gastroparesis must have delayed gastric emptying shown using C13 breath test\n\nExclusion Criteria:\n\nDiabetic or post-surgical gastroparesis\nTreatment modifying GI motility (prokinetics, opioids...)\nParkinson or neurologic disease\nEvoluting inflammatory process or neoplasia\nTreatment modifying coagulation\nPatients not affiliated to the French healthcare insurance",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Idiopathic gastroparesis and healthy volunteers",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Guillaume Gourcerol, MD, PhD",
                "OverallOfficialAffiliation":"Chu de rouen",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Service de Physiologie",
                "LocationCity":"Rouen",
                "LocationState":"Haute normandie",
                "LocationZip":"76000",
                "LocationCountry":"France"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000018589",
                "ConditionMeshTerm":"Gastroparesis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000013272",
                "ConditionAncestorTerm":"Stomach Diseases"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000010243",
                "ConditionAncestorTerm":"Paralysis"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M19269",
                "ConditionBrowseLeafName":"Gastroparesis",
                "ConditionBrowseLeafAsFound":"Gastroparesis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14645",
                "ConditionBrowseLeafName":"Stomach Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11740",
                "ConditionBrowseLeafName":"Paralysis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T2457",
                "ConditionBrowseLeafName":"Gastroparesis",
                "ConditionBrowseLeafAsFound":"Gastroparesis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}