{
  "FullStudy":{
    "Rank":218101,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512719",
          "OrgStudyIdInfo":{
            "OrgStudyId":"040411-HMO-CTIL"
          },
          "Organization":{
            "OrgFullName":"Hadassah Medical Organization",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders",
          "OfficialTitle":"POEM a Novel Endoscopic Treatment for Achalasia",
          "Acronym":"POEM"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2016",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2013"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2018",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2018",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 15, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 12, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 13, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Yoav Mintz",
            "ResponsiblePartyInvestigatorTitle":"Senior Lecturer",
            "ResponsiblePartyInvestigatorAffiliation":"Hadassah Medical Organization"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hadassah Medical Organization",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Achalasia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"25",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"POEM procedure",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients with achalasia that undergo POEM",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: POEM"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"POEM",
                "InterventionDescription":"Per Oral Endoscopic Myotomy for achalasia",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "POEM procedure"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Resolution of dysphagia",
                "PrimaryOutcomeTimeFrame":"up to 6 months postoperatively"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with Achalasia whom are candidates for Heller Myotomy\n\nExclusion Criteria:\n\nPerforation of LES during dilatation\nPregnant women\nmentally ill patients",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Yoav Mintz, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"97226776404",
                "CentralContactEMail":"ymintz@hadasaah.org.il"
              },{
                "CentralContactName":"Hadas Lemberg, PhD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"0097226777572",
                "CentralContactEMail":"lhadas@hadassah.org.il"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Yoav Mintz, MD",
                "OverallOfficialAffiliation":"Hadassah Medical Organization",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hadassah Medical Center",
                "LocationStatus":"Recruiting",
                "LocationCity":"Jerusalem",
                "LocationZip":"12000",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Yoav Mintz, Associate Professor of Surgery",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"Hadassah Medical Center",
                "LocationStatus":"Recruiting",
                "LocationCity":"Jerusalem",
                "LocationZip":"12000",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Ronit Ungar",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+972-26779694",
                      "LocationContactEMail":"ronitu@hadassah.org.il"
                    }
                  ]
                }
              },{
                "LocationFacility":"Hadassah Medical Organization",
                "LocationStatus":"Recruiting",
                "LocationCity":"Jerusalem",
                "LocationZip":"91120",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Hadas Lemberg, PhD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"0097226777572",
                      "LocationContactEMail":"lhadas@hadassah.org.il"
                    },{
                      "LocationContactName":"Mahmoud Abu Gazala, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Harold Jacob, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Yael Kopelman, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"Hadassah Medical Organization Ein-Kerem campus",
                "LocationStatus":"Recruiting",
                "LocationCity":"Jerusalem",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Yoav Mintz, MD",
                      "LocationContactRole":"Contact"
                    },{
                      "LocationContactName":"Yoav Mintz, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004931",
                "ConditionMeshTerm":"Esophageal Achalasia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000015154",
                "ConditionAncestorTerm":"Esophageal Motility Disorders"
              },{
                "ConditionAncestorId":"D000003680",
                "ConditionAncestorTerm":"Deglutition Disorders"
              },{
                "ConditionAncestorId":"D000004935",
                "ConditionAncestorTerm":"Esophageal Diseases"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6664",
                "ConditionBrowseLeafName":"Esophageal Achalasia",
                "ConditionBrowseLeafAsFound":"Achalasia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16457",
                "ConditionBrowseLeafName":"Esophageal Motility Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16458",
                "ConditionBrowseLeafName":"Esophageal Spasm, Diffuse",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5465",
                "ConditionBrowseLeafName":"Deglutition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6668",
                "ConditionBrowseLeafName":"Esophageal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3004",
                "ConditionBrowseLeafName":"Idiopathic Achalasia",
                "ConditionBrowseLeafAsFound":"Achalasia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T975",
                "ConditionBrowseLeafName":"Cardiospasm",
                "ConditionBrowseLeafAsFound":"Achalasia",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC09",
                "ConditionBrowseBranchName":"Ear, Nose, and Throat Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}