Intrathecal Pump Refills at Home

NCT05015933 | Completed

• 1 other identifier: ESCAPE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrathecal Drug Delivery; Implantable Pump; Telemedicine

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (11)

• Environmental safety

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

• Clean, sterile procedure

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

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

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

• Adverse events

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

• Patient feasibility

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

Study Arms (1)

Refill at home

EXPERIMENTAL

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

Procedure: Pump refill procedure at home

Interventions

Pump refill procedure at home PROCEDURE

Implantable pump refill is performed at home

Refill at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Moens Maarten: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 23, 2021
• Study Start: August 9, 2021
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

BE (1)