Intrathecal Pump Refills at Home

August 23, 2021 updated by: Moens Maarten

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Jette, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Refill at home
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill
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.
Once, at the moment of the study visit, immediately after the pump refill

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moens Maarten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Escape

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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