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Intrathecal Pump Refills at Home or at the Hospital
Sponsor: Moens Maarten
Summary
The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable. Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.
Official title: Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2025-10-15
Completion Date
2028-10-01
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Refill at the hospital
Intrathecal pump refill procedure conducted at the hospital
Refill at home
Intrathecal pump refill procedure conducted at the home of the patient
Locations (1)
UZ Brussel
Jette, Belgium