Intrathecal Drug DeliveryNCT05015933
Intrathecal Pump Refills at Home
A study testing Pump refill procedure at home in people with Intrathecal Drug Delivery and Implantable Pump, run by Moens Maarten at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrathecal Drug Delivery, Implantable Pump, Telemedicine
- What is being tested?
- Pump refill procedure at home
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Aug 2021to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient receives intrathecal drug therapy
- Patient is at least 18 years old
- Native French-or Dutch speaking persons.
Who cannot join
- Patients < 18 years old.
- No native Dutch or French speaking persons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intrathecal Drug Delivery, Implantable Pump, Telemedicine
- Being tested
- Pump refill procedure at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pump refill procedure at homeProcedure or surgery
Implantable pump refill is performed at home
| Study group | Role | What they receive |
|---|---|---|
| Refill at home | Experimental | Patients will have one pump refill at home instead of at the hospital. Receives: Procedure: Pump refill procedure at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Secondary outcomes (11)
Environmental safety
An open question in which the physician can indicate whether there were any situations that were not safe.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Clean, sterile procedure
An open question in which the physician can mention all potential risks.
Measured: Once, at the moment of the study visit, immediately after the pump refill
An objective confirmation of correct injection in the pump by ultrasound.
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.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Adverse events
All adverse events will systematically be reported by the physician.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Patient feasibility
A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by teleconsultant
Quality of the internet connection will be evaluated by the teleconsultant.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Time burden for teleconsultant
The time will be measured from the beginning until the end of the call.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Physician feasibility
A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by physician
Quality of the internet connection will be evaluated by the physician.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Time burden for physician
The time will be measured from the beginning until the end of the call.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Patient preference
Patients will be asked to indicate whether they prefer to have their next refill at home.
Measured: Once, at the moment of the study visit, immediately after the pump refill
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start9 Aug 2021
- Primary completion11 Aug 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal Drug DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015933
- Sponsor's protocol ID
- ESCAPE
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05015933
- Acronym / sponsor ID
- ESCAPE
- Conditions
- Intrathecal Drug Delivery, Implantable Pump, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refill at home | Experimental | Procedure: Pump refill procedure at homePatients will have one pump refill at home instead of at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient receives intrathecal drug therapy
- Patient is at least 18 years old
- Native French-or Dutch speaking persons.
Key exclusion criteria (2 listed)
- Patients < 18 years old.
- No native Dutch or French speaking persons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pump refill procedure at homeImplantable pump refill is performed at home | Procedure or surgery | Refill at home |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
Environmental safety
Time frame: 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 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
Adverse events
Time frame: 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
Quality of teleconsultant connection by teleconsultant
Time frame: 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
Physician feasibility
Time frame: 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
Time burden for physician
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pump refill procedure at home in people with Intrathecal Drug Delivery and Implantable Pump, run by Moens Maarten at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Once, at the moment of the study visit, immediately after the pump refill). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.