[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622611":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":46,"studyPopulation":40,"armGroups":47,"interventions":59,"overallOfficials":69,"centralContacts":73,"locations":82,"responsibleParty":100,"collaborators":102,"id":108,"slug":40,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":40,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":40,"enrollmentInfo":116,"targetDuration":40,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":133,"whyStopped":40,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Nordsjaellands Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Catheter Dislocation Distance","The absolute distance (in millimeters) between the position of the catheter delivery orifice at initial placement and its position just before removal. The position is verified by ultrasound imaging using hydrodissection with a local anesthetic bolus to identify the orifice.","From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).",[14,18,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"Time on Task","Time required for catheter placement, measured from initiation of skin disinfection to final skin fixation using a stopwatch (seconds).","At time of procedure (Day 0)",{"measure":19,"description":20,"timeFrame":17},"Primary Placement Success Rate","Proportion of successful primary catheter placements, defined as the accurate position of the delivery orifice verified by ultrasound",{"measure":22,"description":23,"timeFrame":24},"Catheter Clinical Performance (Sensory Block)","Sensitivity to a cooled vial (5°C) over the cutaneous innervation area (Tibial\u002FPeroneal for sciatic; Saphenous for saphenous nerve).","Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.",{"measure":26,"description":27,"timeFrame":28},"Catheter Retraction Force","The force required for catheter removal, measured with a digital handheld force transducer (Newtons).","Day 3 (just before surgery)",{"measure":30,"description":31,"timeFrame":32},"Pain Intensity (NRS)","Participant-reported pain at rest using a Numeric Rating Scale (0-10, where 0 is no pain and 10 the worst thinkable pain)","Day 0, Day 1, Day 2 and Day 3",{"measure":34,"description":35,"timeFrame":36},"Cumulative Opioid Consumption","Total intravenous (IV) morphine equivalents administered while the catheter is in place.","Day 0 to day 3 (Entire study duration)",{"measure":38,"description":39,"timeFrame":36},"Incidence of Adverse Events","Number and nature of complications including infection, back-leakage, or device-related issues.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":6,"observationalModel":40,"timePerspective":40,"maskingInfo":44},"NON_RANDOMIZED","SEQUENTIAL",{"masking":45,"maskingDescription":40,"whoMasked":40},"NONE","Background and Rationale Peripheral nerve blocks are a standard of care for regional anesthesia; however, traditional catheters are prone to secondary dislocation (slipping out of place), which leads to inadequate pain control. This study evaluates a novel prototype catheter designed with an internal fixation mechanism intended to secure the catheter tip at the target site. Additionally, the system utilizes a refined deployment mechanism designed for rapid and precise placement by the clinician.\n\nStudy Objective The primary objective of this pilot study is to evaluate the stability and migration rate of the catheter tip over a multi-day period. Secondarily, the study will assess the technical feasibility and speed of the deployment system.\n\nStudy Design and Safety Model This is a single-arm, non-randomized, proof-of-concept trial. To ensure maximum participant safety during the testing of this new hardware, the study utilizes a femoral amputation model.\n\nThe catheter will be placed in participants who are already scheduled for a femoral amputation. The insertion site and the final position of the catheter tip will be located distal to (below) the anticipated surgical amputation line. This ensures that the tissue involved in the study is part of the limb intended for removal, thereby minimizing any long-term risk of nerve injury or local tissue complications for the participant.\n\nProcedures\n\nBaseline \\& Placement: Eligible participants will have the prototype catheter placed via ultrasound guidance several days prior to their scheduled surgery. The time required for deployment will be recorded.\n\nMonitoring Period: The position of the catheter tip will be monitored at set intervals using ultrasound imaging to track any migration or dislocation from the initial placement site.\n\nRemoval: The catheter will be removed in the operating room immediately prior to the commencement of the scheduled amputation.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Sciatic Nerve Catheter","EXPERIMENTAL","All participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line.",[53],"Device: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve",{"label":55,"type":50,"description":56,"interventionNames":57},"Saphenous Nerve Catheter","If the planned amputation line is high enough on the femur to allow for distal placement, participants will also receive a second prototype fixation catheter near the saphenous nerve.",[58],"Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":40},"DEVICE","Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve","A peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system.\n\nCatheters are placed under ultrasound guidance.",[49],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":40},"Novel Internal Fixation Nerve Block Catheter - Saphenous nerve","Placement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).",[55],[70],{"name":71,"affiliation":5,"role":72},"Christoffer C Jørgensen, MD, PhD","PRINCIPAL_INVESTIGATOR",[74,78],{"name":71,"role":75,"phone":76,"phoneExt":40,"email":77},"CONTACT","+45 48296659","christoffer.calov.joergensen.01@regionh.dk",{"name":79,"role":75,"phone":80,"phoneExt":40,"email":81},"Kai H Lange, MD, PhD","+45 48294252","kai.henrik.wiborg.lange@regionh.dk",[83],{"facility":84,"status":40,"city":85,"state":86,"zip":40,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Hvidovre Hospital","Copenhagen","Capital Region","Denmark","DK",{"type":90,"coordinates":91},"Point",[92,93],12.56553,55.67594,{"lat":93,"lon":92},[96],{"name":97,"role":75,"phone":98,"phoneExt":40,"email":99},"Tazio Maleitzke, MD, PhD","+45 20141988","tazio.maleitzke@regionh.dk",{"type":101,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[103,105],{"name":104,"class":6},"Hvidovre University Hospital",{"name":106,"class":107},"Nordstar Medical","UNKNOWN","100622611",false,"NCT07385872","Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter","Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled for elective transfemoral amputation\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics","ALL","18 Years",{"count":117,"type":118},15,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use.\n\nThe main questions the study aims to answer are:\n\nDoes the catheter tip stay in the correct position over time without moving or slipping (dislocation)?\n\nCan the catheter be placed quickly and accurately using the new deployment system?\n\nResearchers will test this prototype in a small group of participants. There is no comparison group for this initial study.\n\nParticipants will:\n\nHave the catheter placed near a nerve in their leg a few days before a scheduled femoral (leg) amputation.\n\nUndergo imaging or checks to see if the catheter has moved.\n\nHave the catheter removed just before their scheduled surgery.\n\nThe catheter will be placed in an area of the leg that is already scheduled to be removed during surgery. This ensures that the study carries minimal risk to the participants.",[124,125,126],"Primary Condition: Nerve Block","Secondary Condition: Catheter Displacement","Focus of Study: Sciatic Nerve",[128,129,130,131,132],"Sciatic Nerve Block","Peripheral Nerve Catheter","Catheter Migration","Internal Fixation Device","Proof-of-Concept Study","NOT_YET_RECRUITING","2026-02-03",{"date":136,"type":137},"2026-02-04","ACTUAL",{"date":139,"type":118},"2026-02",{"date":141,"type":118},"2026-11",{"name":5,"class":6},1]