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Intrathecal Pump Refills at Home or at the Hospital

Study acronym: IMPROVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07727798
Lead Sponsor Moens Maarten
Conditions
(from sponsor)		 Intrathecal Pump Refill
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov