Oxygenation in Vascular Lesions of the Colon

Launched by UNIVERSITY OF CHICAGO · Jan 19, 2024

Nctid: NCT06230731

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T120", "name"=>"Cola", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Herbal and Botanical", "abbrev"=>"HB"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SCREENING", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2029-02-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-07", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-08", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-02-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Quantitative analysis of colonic oxygen saturation levels", "timeFrame"=>"baseline-12 months", "description"=>"Colonic oxygen saturation levels will be compared between patients with vascular lesions of the colon and healthy controls."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Vascular Lesion"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.", "detailedDescription"=>"The etiology of acquired vascular abnormalities of the large bowel (i.e. angiodysplasia, AVM, hemangiomas of the cecum. etc.) are unknown. These lesions typical appear as ectatic, dilated, and tortuous blood vessels within the submucosa and mucosa of the GI tract. In some patients they are the cause of acute large volume bleeding or a slower chronic bleed that manifests as chronic iron deficiency anemia. These lesions are more common in older individuals and those with underlying cardiac, pulmonary, and renal disease. As such, it is hypothesized that these lesions may result from chronic hypoxia. This study aims to evaluate oxygenation of the colon in people with acquired vascular abnormalities in the proximal colon compared to healthy controls."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"89 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Undergo standard of care colonoscopy\n* People with a history of vascular lesions of the colon\n* People with healthy colon\n* 18 - 89 years of age\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Age \\> 90 years\n* People with ulcerations in at ascending colon opposite the ileocecal valve\n* Previous colon surgery"}, "identificationModule"=>{"nctId"=>"NCT06230731", "briefTitle"=>"Oxygenation in Vascular Lesions of the Colon", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Oxygenation in Vascular Lesions of the Colon", "orgStudyIdInfo"=>{"id"=>"IRB23-1273"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Vascular abnormality group", "description"=>"People with acquired vascular abnormalities in the proximal colon", "interventionNames"=>["Other: Oxygen saturation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Control group", "description"=>"People with healthy colon", "interventionNames"=>["Other: Oxygen saturation"]}], "interventions"=>[{"name"=>"Oxygen saturation", "type"=>"OTHER", "description"=>"Measure oxygen levels in 5 proximal colon mucosa locations.", "armGroupLabels"=>["Control group", "Vascular abnormality group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Joel Pekow, MD", "role"=>"CONTACT", "email"=>"jpekow@bsd.uchicago.edu", "phone"=>"773-834-8632"}, {"name"=>"Kristi Kearney, RN", "role"=>"CONTACT", "email"=>"kkearney@bsd.uchicago.edu", "phone"=>"773-834-7414"}], "facility"=>"University of Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}], "centralContacts"=>[{"name"=>"Joel Pekow, MD", "role"=>"CONTACT", "email"=>"jpekow@bsd.uchicago.edu", "phone"=>"(773) 834-8632"}, {"name"=>"Kristi Kearney, RN", "role"=>"CONTACT", "email"=>"Kkearney@bsd.uchicago.edu", "phone"=>"773-834-7414"}], "overallOfficials"=>[{"name"=>"Joel Pekow, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Chicago"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Chicago", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}