Intrathecal Pump Refills at Home

Moens Maarten

Status: Completed

Conditions: Intrathecal Drug Delivery; Implantable Pump; Telemedicine

Treatments: Procedure: Pump refill procedure at home

Study type: Interventional

Funder types: Other

Identifiers

NCT05015933

ESCAPE

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Refill at home

Experimental group

Description:

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

Treatment:

Procedure: Pump refill procedure at home