Nctid:
NCT06612541
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000012178", "term"=>"Retinopathy of Prematurity"}, {"id"=>"D000047928", "term"=>"Premature Birth"}], "ancestors"=>[{"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000007752", "term"=>"Obstetric Labor, Premature"}, {"id"=>"D000007744", "term"=>"Obstetric Labor Complications"}, {"id"=>"D000011248", "term"=>"Pregnancy Complications"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007235", "term"=>"Infant, Premature, Diseases"}, {"id"=>"D000007232", "term"=>"Infant, Newborn, Diseases"}], "browseLeaves"=>[{"id"=>"M25869", "name"=>"Premature Birth", "asFound"=>"Prematurity", "relevance"=>"HIGH"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "asFound"=>"Retinopathy", "relevance"=>"HIGH"}, {"id"=>"M15013", "name"=>"Retinopathy of Prematurity", "asFound"=>"Retinopathy of Prematurity", "relevance"=>"HIGH"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M10772", "name"=>"Obstetric Labor, Premature", "relevance"=>"LOW"}, {"id"=>"M10764", "name"=>"Obstetric Labor Complications", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10279", "name"=>"Infant, Premature, Diseases", "relevance"=>"LOW"}, {"id"=>"M10276", "name"=>"Infant, Newborn, Diseases", "relevance"=>"LOW"}, {"id"=>"T4981", "name"=>"Retinopathy of Prematurity", "asFound"=>"Retinopathy of Prematurity", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>90}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2030-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-21", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Retinal imaging in pediatric ROP patients", "timeFrame"=>"Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first", "description"=>"Real-time noninvasive optical imaging of the retina will be performed out to the ora serrata and ROP diagnostic markers will be evaluated in post-processing and compared against clinical examination"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Retinopathy of Prematurity", "ROP", "Prematurity", "OCT Imaging"], "conditions"=>["Retinopathy of Prematurity (ROP)", "ROP Examination"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.", "detailedDescription"=>"Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP. Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening. No additional treatments will be given to study patients to benefit HH-SECTR imaging (e.g., sedation, dilation, etc.). Study patients will primarily be imaged in the NICU, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. Because this study will evaluate diagnostic features prognostic of ROP progression and severity, HH-SECTR imaging will be performed until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first. Both eyes will undergo HH-SECTR imaging. Diagnostic imaging data will be analyzed following each imaging session. No experimental data will be used to alter the management of patients from the standard-of-care.\n\nResearch materials obtained from subjects will include digital HH-SECTR images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables.\n\nThe duration of the study will be 5 years. The study records and information will be indefinitely archived per NIH rules using the methods noted above."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"34 weeks", "minimumAge"=>"24 weeks", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Preterm male and female infants born at 24-34 weeks gestational age and weighing \\<1500g at birth.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Preterm male and female infants born at 24-34 weeks gestational age and weighing \\<1500g at birth\n\nExclusion Criteria:\n\n* Infants surgically treated for ROP\n* Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team"}, "identificationModule"=>{"nctId"=>"NCT06612541", "acronym"=>"ROP Imaging", "briefTitle"=>"Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity", "organization"=>{"class"=>"OTHER", "fullName"=>"Vanderbilt University Medical Center"}, "officialTitle"=>"Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity", "orgStudyIdInfo"=>{"id"=>"231251"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"37232", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt University Medical Center", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}], "centralContacts"=>[{"name"=>"Irina De la Huerta, MD, PhD", "role"=>"CONTACT", "email"=>"CTU.ROP@vumc.org", "phone"=>"615-936-2020"}, {"name"=>"Marybeth Carter", "role"=>"CONTACT", "email"=>"CTU.ROP@vumc.org", "phone"=>"615-936-1639"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Vanderbilt University Medical Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institutes of Health (NIH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Irina De la Huerta", "investigatorAffiliation"=>"Vanderbilt University Medical Center"}}}}
