Nctid:
NCT06224933
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DEVICE_FEASIBILITY", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>12}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2023-11-22", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.", "timeFrame"=>"1 day"}, {"measure"=>"Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.", "timeFrame"=>"7 days"}], "secondaryOutcomes"=>[{"measure"=>"Procedure time", "timeFrame"=>"1 day", "description"=>"Total procedure time."}, {"measure"=>"Number of MRI scans", "timeFrame"=>"1 day", "description"=>"Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded."}, {"measure"=>"Clinical impressions of the system use and utility", "timeFrame"=>"1 Day", "description"=>"The operator will complete a usability form that captures ease of use using the Likert scale."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Infections", "Pain", "Diagnosis", "Image Guided Needle Biopsy"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.", "detailedDescription"=>"This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "minimumAge"=>"3 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, ages 3 to 21\n* Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent themselves or through their parents.\n* Patients under 3 years of age\n* Patients over 300 pounds.\n* Patients who are claustrophobic and unable to tolerate MRI-guided procedure.\n* Contraindications to MRI such as MR-unsafe implants."}, "identificationModule"=>{"nctId"=>"NCT06224933", "briefTitle"=>"Augmented Reality For MRI-Guided Interventions", "organization"=>{"class"=>"OTHER", "fullName"=>"Children's National Research Institute"}, "officialTitle"=>"Augmented Reality Real-Time Guidance for MRI-Guided Interventions", "orgStudyIdInfo"=>{"id"=>"STUDY00000648"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Patients Undergoing Augmented Reality Image-Guided Needle Procedures", "description"=>"Patients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.", "interventionNames"=>["Device: Augmented Reality System"]}], "interventions"=>[{"name"=>"Augmented Reality System", "type"=>"DEVICE", "description"=>"Subjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.", "armGroupLabels"=>["Patients Undergoing Augmented Reality Image-Guided Needle Procedures"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20010", "city"=>"Washington", "state"=>"District of Columbia", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Karun Sharma, MD, PhD", "role"=>"CONTACT", "email"=>"kvsharma@childrensnational.org", "phone"=>"202-476-3791"}, {"name"=>"Emily Leibold, BSE", "role"=>"CONTACT", "email"=>"eleibold@childrensnational.org", "phone"=>"202-476-5522"}, {"name"=>"Karun Sharma, MD/PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Children's National Hospital", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}], "centralContacts"=>[{"name"=>"Emily Leibold, BSE", "role"=>"CONTACT", "email"=>"eleibold@childrensnational.org", "phone"=>"202-476-5522"}], "overallOfficials"=>[{"name"=>"Karun Sharma, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Children's National Research Institute"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Children's National Research Institute", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of Interventional Radiology", "investigatorFullName"=>"Karun Sharma MD", "investigatorAffiliation"=>"Children's National Research Institute"}}}}
