Nctid:
NCT06225180
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000038", "term"=>"Abscess"}], "ancestors"=>[{"id"=>"D000013492", "term"=>"Suppuration"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000007249", "term"=>"Inflammation"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M37", "name"=>"Abscess", "asFound"=>"Abscess", "relevance"=>"HIGH"}, {"id"=>"M16273", "name"=>"Suppuration", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-06-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-29", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2023-11-14", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-29", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of repeat interventions prior to resolution of abscess(s)", "timeFrame"=>"5 years", "description"=>"Determine the superiority of aspiration vs incision as primary intervention in treatment of breast abscesses"}], "secondaryOutcomes"=>[{"measure"=>"Antibiotic days", "timeFrame"=>"5 years", "description"=>"number of days used antibiotics"}, {"measure"=>"Repeat aspiration", "timeFrame"=>"5 years", "description"=>"Frequency of aspiration"}, {"measure"=>"Return to Emergency Department ( ED)", "timeFrame"=>"5 years", "description"=>"Number of times of ED visit"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Breast Abscess"]}, "descriptionModule"=>{"briefSummary"=>"Breast abscesses are an unfortunate pathology that develop in patients, and treatment is often painful and unpleasant. The goal of this study is to identify risk factors associated with failure of aspiration as a primary intervention as opposed to incision and drainage in the hopes of adequately treating patients at initial presentation.", "detailedDescription"=>"The pendulum has now swung toward minimally invasive aspiration as the primary treatment modality, with multiple studies reporting superior cosmetic results. However, patients in these studies often required repeat breast aspirations, and sometimes ultimately required incision and drainage. Aspiration first for treatment of breast abscess may not be a wise choice for all patients if it results in increased antibiotic days, return to emergency department (ED)/increased cost, or prolonged pain from multiple procedures. Several studies have identified varying risk factors for aspiration failure as primary intervention for breast abscesses. More data is needed to confirm the true risk factors for failure."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"18 years of age\n\n• New diagnosis of N61.1 recorded in their EMR", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* • ≥18 years of age\n\n * New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)\n\nExclusion Criteria:\n\n* • \\<18 years of age\n\n * Pregnant\n * Incarcerated"}, "identificationModule"=>{"nctId"=>"NCT06225180", "briefTitle"=>"Review of Breast Abscess Management", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Review of Breast Abscess Management", "orgStudyIdInfo"=>{"id"=>"021.TRA.2023.D"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Colette Ngo Ndjom, MS", "role"=>"CONTACT", "email"=>"ColetteNgoNdjom@mhd.com", "phone"=>"410-947-4681"}], "facility"=>"Clinical Research Institute at Methodist Health System", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Colette Ngo Ndjom, MS", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681"}, {"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"217-947-4680"}, {"name"=>"Conner McDaniel, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Methodist Dallas Medical Center", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "centralContacts"=>[{"name"=>"Kavya Vinod Mankulangara", "role"=>"CONTACT", "email"=>"MHSIRB@mhd.com", "phone"=>"214-947-1281"}, {"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681"}], "overallOfficials"=>[{"name"=>"Conner McDaniel, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Midlothian Medical Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
