Simulation-Based Intrathecal Pump Refill Training

NCT07854834 | Not Yet Recruiting

• 1 other identifier: 26298_REFILL-IT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Intrathecal drug delivery; Pump refill; Learning curve; Simulation-based; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure

  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

  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

  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

  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

  Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

Study Arms (1)

Simulation-based intrathecal pump refill training

EXPERIMENTAL

Procedure: Simulation-based intrathecal pump refill training

Interventions

Simulation-based intrathecal pump refill training PROCEDURE

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.

Simulation-based intrathecal pump refill training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare professionals
• (Healthcare) students;
• Aged ≥18 years;
• No prior independent performance of intrathecal pump refill procedures;
• Dutch speaking.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel/VUB

Jette, 1090, Belgium

Location

Central Study Contacts

Maarten Moens, MD PhD MBA

CONTACT

+3224775514; stimulusresearchgroup@gmail.com

Lisa Goudman, MSC, PhD, MBA

CONTACT

lisa.goudman@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

BE (1)