Home or Hospital Intrathecal Pump Refills: A Patient Trial
Official title: Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial
Run by Universitair Ziekenhuis Brussel · NCT07727798 · Data updated 2026-11-12
This study tests whether refilling an implanted intrathecal pump at home is as safe and comfortable as refilling it in the hospital for adults with chronic pain or severe spasticity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07727798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in Belgium currently using intrathecal drug delivery with stable dosing for at least 3 months and who speak Dutch, French, or English.
✕Probably not a fit
Patients with concerns about maintaining medical supervision or those who do not have suitable home support may not experience benefit from home refills.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The IMPROVE study is a randomized, cross-over trial comparing intrathecal pump refills done at home versus at the hospital. Eighty-two adults in Belgium with an implanted intrathecal pump will each have four refill procedures: two at home and two in the hospital, in random order. The aim is to see if home refills can reduce stress and burden for patients and caregivers while maintaining safety and efficacy of therapy. Eligible participants must be actively receiving intrathecal drug delivery, have a stable dose for at least three months, and speak Dutch, French, or English. Exclusion criteria include limited life expectancy, not yet receiving an implant, or not residing in Belgium.
Why it matters
Potential benefit: If home refills prove safe and comfortable, patients may experience less travel burden, reduced stress, and similar clinical outcomes compared with hospital refills.
How similar studies have gone: Preliminary data from early pilots suggest home-based refills can be safe and more comfortable, supporting further evaluation in a randomized cross-over design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Actively receiving Intrathecal drug delivery * Stable medication dosage for at least 3 months * Dutch, French or English speaking adults Exclusion Criteria: * Life expectancy \< 6 months * Patients planned for but not yet received Intrathecal drug delivery implant * No residence in Belgium
Where it's running
-
UZ Brussel
Jette, Belgium Recruiting
Study contacts
- Study coordinator: Maarten Moens, MD PhD
- Email: stimulusresearchgroup@gmail.com
- Phone: +3224775514
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.