Intrathecal Pump Refills at Home

NCT ID: NCT05015933

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2021-08-11

Brief Summary

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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.

Detailed Description

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Conditions

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Intrathecal Drug Delivery Implantable Pump Telemedicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Refill at home

Patients will have one pump refill at home instead of at the hospital.

Group Type EXPERIMENTAL

Pump refill procedure at home

Intervention Type PROCEDURE

Implantable pump refill is performed at home

Interventions

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Pump refill procedure at home

Implantable pump refill is performed at home

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moens Maarten

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ESCAPE

Identifier Type: -

Identifier Source: org_study_id

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