Intrathecal Drug DeliveryREFILL-ITNCT07854834
Simulation-Based Intrathecal Pump Refill Training
A study testing Simulation-based intrathecal pump refill training in people with Intrathecal Drug Delivery, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intrathecal Drug Delivery
- What is being tested?
- Simulation-based intrathecal pump refill training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare professionals
- (Healthcare) students;
- Aged ≥18 years;
- No prior independent performance of intrathecal pump refill procedures;
- Dutch speaking.
Who cannot join
- Visual impairments preventing participation in stimulated-based intrathecal pump training;
- Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa Goudman, MSC, PhD, MBA contact
Belgium1 site
UZ Brussel/VUB
Jette, 1090
Maarten Moens, +3224775514, stimulusresearchgroup@gmail.com
Ulrike Van Hoey, MSc
About this study
Official title: Optimizing Intrathecal Pump Refill Training: A Simulation-Based Study of Learning Curves and Procedural Competence.
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.
- Conditions
- Intrathecal Drug Delivery
- Being tested
- Simulation-based intrathecal pump refill training
- Keywords
- Intrathecal drug delivery, Pump refill, Learning curve, Simulation-based, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based intrathecal pump refill trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-based intrathecal pump refill training | Experimental | Not described Receives: Procedure: Simulation-based intrathecal pump refill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal Drug DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854834
- Sponsor's protocol ID
- 26298_REFILL-IT
- Acronym
- REFILL-IT
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Intrathecal Pump Refill Training: A Simulation-Based Study of Learning Curves and Procedural Competence.
- ClinicalTrials.gov ID
- NCT07854834
- Acronym / sponsor ID
- REFILL-IT / 26298_REFILL-IT
- Conditions
- Intrathecal Drug Delivery
- Keywords
- Intrathecal drug delivery, Pump refill, Learning curve, Simulation-based, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation-based intrathecal pump refill training | Experimental | Procedure: Simulation-based intrathecal pump refill training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthcare professionals
- (Healthcare) students;
- Aged ≥18 years;
- No prior independent performance of intrathecal pump refill procedures;
- Dutch speaking.
Key exclusion criteria (2 listed)
- Visual impairments preventing participation in stimulated-based intrathecal pump training;
- Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based intrathecal pump refill trainingThe 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. | Procedure or surgery | Simulation-based intrathecal pump refill training |
Primary outcome
Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
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
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.
9 secondary outcomes
Total Objective Structured Assessment of Technical Skills (OSATS) score per 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
Attempt-level success or failure
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Goudman, MSC, PhD, MBA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based intrathecal pump refill training in people with Intrathecal Drug Delivery, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, MD PhD MBA (+3224775514, stimulusresearchgroup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.