Skip to main content
OpenTrials
Completed

NCT Number: NCT05015933

Intrathecal Pump Refills at Home

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrathecal Drug Delivery Implantable Pump Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient receives intrathecal drug therapy
  • Patient is at least 18 years old
  • Native French-or Dutch speaking persons.

Exclusion criteria

  • Patients < 18 years old.
  • No native Dutch or French speaking persons.

Treatment and study plan

Pump refill procedure at home

Procedure

Implantable pump refill is performed at home

Primary outcomes

  1. Patient satisfaction

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.

  2. Successful pump refill

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A binary variable to indicate success or failure of this intervention, reported by the physician.

  3. Patient safety

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.

  4. Physician safety

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.

Secondary outcomes

  1. Environmental safety

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    An open question in which the physician can indicate whether there were any situations that were not safe.

  2. Clean, sterile procedure

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    An open question in which the physician can mention all potential risks.

  3. An objective confirmation of correct injection in the pump by ultrasound.

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    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.

  4. Adverse events

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    All adverse events will systematically be reported by the physician.

  5. Patient feasibility

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.

  6. Quality of teleconsultant connection by teleconsultant

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    Quality of the internet connection will be evaluated by the teleconsultant.

  7. Time burden for teleconsultant

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    The time will be measured from the beginning until the end of the call.

  8. Physician feasibility

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.

  9. Quality of teleconsultant connection by physician

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    Quality of the internet connection will be evaluated by the physician.

  10. Time burden for physician

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    The time will be measured from the beginning until the end of the call.

  11. Patient preference

    Time frame: Once, at the moment of the study visit, immediately after the pump refill

    Patients will be asked to indicate whether they prefer to have their next refill at home.

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Official study title

Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.