[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509104":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Handheld traditional ultrasound","ACTIVE_COMPARATOR","Traditional US will be used to compare number of needle manipulations to the handheld US.",[13],"Device: Traditional ultrasound",{"label":15,"type":6,"description":16,"interventionNames":17},"Handheld Automated ultrasound","Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.",[18],"Device: Automated ultrasound",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Traditional ultrasound","Labor epidural will be performed after marking patient skin using traditional ultrasound guidance",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Automated ultrasound","Labor epidural will be performed after marking patient skin using an automated ultrasound device",[15],[31],{"name":32,"affiliation":5,"role":33},"Antonio Gonzalez, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","4133869415","Antonio.Gonzalez-fiol@yale.edu",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"New Haven","Connecticut","06510","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100509104","the-impact-of-needle-manipulation-and-accuracy-between-hand-held-automatic-and-traditional-ultrasound-device-100509104",false,"NCT05909085","The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device","A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices","Inclusion Criteria:\n\n* ASA-1, ASA-2, and ASA-3\n* Patients with no known back deformities\n* Ability to sit upright for epidural placement\n* No prior lumbar surgery\n* No allergies to ultrasound gel\n\nExclusion Criteria:\n\n* Coagulopathy\n* Low platelet count\n* Allergies to local anesthetics",true,"FEMALE","18 Years","45 Years",{"count":66,"type":67},200,"ESTIMATED","INTERVENTIONAL",[70],"NA","In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\\\u003C 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.",[73],"Labor Analgesia","NOT_YET_RECRUITING","2025-09-10",{"date":77,"type":78},"2025-09-15","ACTUAL",{"date":80,"type":67},"2026-07-01",{"date":82,"type":67},"2026-12",{"name":5,"class":6},1]