An interventional study of Simulation-based intrathecal pump refill training in Intrathecal Drug Delivery, sponsored by Universitair Ziekenhuis Brussel. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Supportive care
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.
Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Simulation-based intrathecal pump refill training
The REFILL-IT study consists of two mandatory phases and an optional third clinical phase. During 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. In 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. Participants 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.
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Number and type of critical procedural errors
The number and type of critical procedural errors occurring during each simulated refill procedure will be recorded.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Total procedure time of a complete simulated refill procedure
The total time required to complete each (simulated) intrathecal pump refill procedure will be recorded.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Time required for individual procedural steps
The time required for individual procedural steps during a (simulated) intrathecal pump refill procedure will be recorded.
Time frame: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universitair Ziekenhuis Brussel