An interventional study of Pump refill procedure at home in Intrathecal Drug Delivery, Implantable Pump and Telemedicine, sponsored by Moens Maarten. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Moens Maarten · Not applicable, Interventional, and Treatment
The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.
Moens Maarten is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will have one pump refill at home instead of at the hospital.
Procedure: Pump refill procedure at home
Implantable pump refill is performed at home
Patient satisfaction
A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Successful pump refill
A binary variable to indicate success or failure of this intervention, reported by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient safety
A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Physician safety
A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Environmental safety
An open question in which the physician can indicate whether there were any situations that were not safe.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Clean, sterile procedure
An open question in which the physician can mention all potential risks.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
An objective confirmation of correct injection in the pump by ultrasound.
After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Adverse events
All adverse events will systematically be reported by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient feasibility
A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by teleconsultant
Quality of the internet connection will be evaluated by the teleconsultant.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Time burden for teleconsultant
The time will be measured from the beginning until the end of the call.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Physician feasibility
A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by physician
Quality of the internet connection will be evaluated by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Time burden for physician
The time will be measured from the beginning until the end of the call.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient preference
Patients will be asked to indicate whether they prefer to have their next refill at home.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Moens Maarten