[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658742":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":48,"interventions":54,"overallOfficials":41,"centralContacts":59,"locations":68,"responsibleParty":94,"collaborators":41,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":41,"enrollmentInfo":107,"targetDuration":41,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":121,"whyStopped":41,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence","The number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence will be determined using Learning Curve Cumulative Sum (LC-CUSUM) analysis.","Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure","Each (simulated) refill procedure will be evaluated using an OSATS-based assessment tool, assessing four predefined domains: aseptic technique, correct port access, volume verification, and procedural safety.",{"measure":18,"description":19,"timeFrame":12},"Attempt-level success or failure","Each (simulated) refill procedure will be classified as successful or failed based on the OSATS score and the occurrence of critical procedural errors.",{"measure":21,"description":22,"timeFrame":12},"Number and type of critical procedural errors","The number and type of critical procedural errors occurring during each simulated refill procedure will be recorded.",{"measure":24,"description":25,"timeFrame":12},"Number and type of procedural errors","Non-critical procedural errors, including minor deviations, delays, and technical difficulties, will be recorded during each (simulated) refill procedure.",{"measure":27,"description":28,"timeFrame":12},"Proportion of participants achieving stable procedural competence within the predefined training phase","The number of participants achieving stable procedural competence according to the predefined LC-CUSUM decision rule will be recorded, or until a maximum of 16 complete simulated refill procedures has been reached.",{"measure":30,"description":31,"timeFrame":12},"Number of participants requiring additional supervised practice or remediation after the predefined training phase","The number of participants requiring additional supervised practice or remediation will be recorded.",{"measure":33,"description":34,"timeFrame":12},"Number of port-access attempts per simulated refill procedure","The number of port-access attempts per (simulated) refill procedure will be recorded, with a maximum of three attempts per procedure.",{"measure":36,"description":37,"timeFrame":12},"Total procedure time of a complete simulated refill procedure","The total time required to complete each (simulated) intrathecal pump refill procedure will be recorded.",{"measure":39,"description":40,"timeFrame":12},"Time required for individual procedural steps","The time required for individual procedural steps during a (simulated) intrathecal pump refill procedure will be recorded.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE",[49],{"label":50,"type":51,"description":41,"interventionNames":52},"Simulation-based intrathecal pump refill training","EXPERIMENTAL",[53],"Procedure: Simulation-based intrathecal pump refill training",[55],{"type":56,"name":50,"description":57,"armGroupLabels":58,"otherNames":41},"PROCEDURE","The REFILL-IT study consists of two mandatory phases and an optional third clinical phase.\n\nDuring the Knowledge Acquisition Phase, participants will receive theoretical and practical instruction through educational videos and a written step-by-step guide. Progression requires successful completion of a knowledge assessment covering the refill procedure.\n\nIn the Skill Development Phase, participants will repeatedly perform simulated intrathecal pump refill procedures using explanted SynchroMed II™ (Medtronic) dummy pumps positioned beneath a 15-mm silicone skin pad. Each procedure will be assessed as either successful or unsuccessful to evaluate the development of procedural competence.\n\nParticipants who achieve stable competence and are physicians legally authorized to perform intrathecal pump refills in Belgium may progress to the Clinical Application Phase, where they will perform refill procedures in patients under the direct supervision of an experienced healthcare professional.",[50],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":41,"email":64},"Maarten Moens, MD PhD MBA","CONTACT","+3224775514","stimulusresearchgroup@gmail.com",{"name":66,"role":62,"phone":41,"phoneExt":41,"email":67},"Lisa Goudman, MSC, PhD, MBA","lisa.goudman@vub.be",[69],{"facility":70,"status":41,"city":71,"state":41,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"UZ Brussel\u002FVUB","Jette","1090","Belgium","BE",{"type":76,"coordinates":77},"Point",[78,79],4.33419,50.87309,{"lat":79,"lon":78},[82,84,87,90,92],{"name":83,"role":62,"phone":63,"phoneExt":41,"email":64},"Maarten Moens",{"name":85,"role":86,"phone":41,"phoneExt":41,"email":41},"Ulrike Van Hoey, MSc","SUB_INVESTIGATOR",{"name":88,"role":89,"phone":41,"phoneExt":41,"email":41},"Maarten Moens, MD, PhD, MBA","PRINCIPAL_INVESTIGATOR",{"name":91,"role":86,"phone":41,"phoneExt":41,"email":41},"Britt Winnepenninckx, MSc",{"name":93,"role":86,"phone":41,"phoneExt":41,"email":41},"Lisa Goudman, MSc, PhD, MBA",{"type":95,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100658742","simulation-based-intrathecal-pump-refill-training-100658742",false,"NCT07854834","Simulation-Based Intrathecal Pump Refill Training","Optimizing Intrathecal Pump Refill Training: A Simulation-Based Study of Learning Curves and Procedural Competence.","REFILL-IT","Inclusion Criteria:\n\n* Healthcare professionals\n* (Healthcare) students;\n* Aged ≥18 years;\n* No prior independent performance of intrathecal pump refill procedures;\n* Dutch speaking.\n\nExclusion Criteria:\n\n* Visual impairments preventing participation in stimulated-based intrathecal pump training;\n* Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.",true,"ALL","18 Years",{"count":108,"type":109},40,"ESTIMATED","INTERVENTIONAL",[43],"Intrathecal drug delivery is an effective treatment option for patients with chronic (non-) cancer pain or spasticity who do not achieve sufficient benefit from conventional therapies. After intrathecal pump implantation, intrathecal pump refilling is an essential postoperative maintenance procedure that requires procedural competence to be performed safely and consistently. Despite the absence of a standardized intrathecal pump refill protocol, the REFFIL-IT study aims to train 40 participants in intrathecal pump refilling. Based on the learning curve during simulation-based training and the number of complete simulated refill procedures required to achieve stable procedural competence, a step-by-step standardized intrathecal pump refill protocol will be developed. The REFILL-IT study aims to contribute to the safe and correct intrathecal pump refilling in patients with chronic (non-) cancer pain and spasticity.",[114],"Intrathecal Drug Delivery",[116,117,118,119,120],"Intrathecal drug delivery","Pump refill","Learning curve","Simulation-based","Neuromodulation","NOT_YET_RECRUITING","2026-10-01",{"date":124,"type":125},"2026-10-02","ACTUAL",{"date":127,"type":109},"2026-11-01",{"date":129,"type":109},"2028-10-01",{"name":5,"class":6},1]