[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517666":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"Attending anesthesiologists who are trained in epidural placement will perform neuraxial procedures (CSEs, Epidural, Spinals through an epidural needle) utilizing loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. The Lumoptik device will be connected between a standard commercially available 17G or 18G, 3.5-inch epidural needle and a saline filled loss of resistance syringe. The anesthesiologist will view the Lumoptik BrightPoint visual display in real time as the epidural procedures are performed. The LOR epidural procedure using haptic feedback will be used as the primary confirmation of correct needle placement in the epidural space. Graphic and color circle information from the Lumoptik visual display will be used as a secondary confirmation of epidural placement.",[13],"Device: Group 1 - Lumoptik BrightPoint Epidural Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Group 1 - Lumoptik BrightPoint Epidural Device","Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.",[9],[21],{"name":22,"affiliation":5,"role":23},"Michael Singleton, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Pa Thor, PhD","CONTACT","646-797-8535","thorp@hss.edu",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Maya Tailor","646-714-6828","tailorm@hss.edu",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital for Special Surgery","RECRUITING","New York","10021","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-74.00597,40.71427,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":10,"email":52},"Justas Lauzadis, PhD","212-774-2946","lauzadisj@hss.edu",{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100517666","lumoptik-brightpoint-reflectometer-device-for-lumbar-epidural-placement-100517666",false,"NCT06020508","Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement","Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement","Inclusion Criteria:\n\n* Any patient undergoing a lumbar neuraxial procedure requiring epidural needle\n* Age 18-99\n\nExclusion Criteria:\n\n* Previous lumbar spine surgery\n* Any known spinal abnormality that would interfere with successfully advancing a needle into the epidural space\n* Any patient requiring epidural needle longer than 4 inches\n* Any contraindication to neuraxial anesthesia\n* Tattoo at the site of epidural insertion",true,"ALL","18 Years","99 Years",{"count":68,"type":69},36,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to test the BrightPoint Epidural device as the first system to use multispectral reflectometry to find the epidural space in lumbar neuraxial procedures requiring epidural needle. The main questions it aims to answer are:\n\n1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?\n2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals?\n\nParticipants will undergo a neuraxial procedure in which the attending anesthesiologist will use the BrightPoint epidural device to form an opinion on its effectiveness in confirming epidural space access.",[73],"Lumbar Spine Surgery",[75,76],"epidural","neuraxial","2025-12-09",{"date":79,"type":80},"2025-12-16","ACTUAL",{"date":82,"type":80},"2023-09-12",{"date":84,"type":69},"2026-07",{"name":5,"class":6},1]