Peritoneal DialysisWEAKIDNCT07131995
Formative Usability Testing Study of a Novel Medical Device for Peritoneal Dialysis (WEAKID)
An observational study of Peritoneal Dialysis, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study aimed to formatively test the usability of the WEarable Artificial KIDney (WEAKID) for peritoneal dialysis (PD) in the device's intended user populations (i.e., nurses and patients). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants represented two populations of intended users of the device, namely nurses and patients. The sample sizes were set at 6 (nurses) and 8 (patients). Prior work on the sample sizes of formative usability testing has shown that these sample sizes suffice to identify the most important design issues.
Who may be able to join
- Nurses: aged 18 years or older, >1 years of professional experience with PD.
- Patients: aged 18 years or older, clinical diagnosis of ESRD, any treatment experience with PD, either current or in the past.
Who cannot join
- Nurses: none.
- Patients: severe physical and/or cognitive impairment, as judged by the researchers.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584CX
About this study
This study aimed to formatively test the usability of the WEarable Artificial KIDney (WEAKID) for peritoneal dialysis (PD) in the device's intended user populations (i.e., nurses and patients).
Read the detailed description
End stage renal disease is a growing health problem worldwide, with a growing number of patients requiring a kidney transplantation. Recent years have seen the development of multiple novel devices for both hemodialysis and peritoneal dialysis (PD), one of these devices being the WEarable Artificial KIDney (WEAKID) for PD. WEAKID uses both sorbent technology and continuous flow PD to improve dialysis efficacy. Here, we present the results of a formative usability testing study of WEAKID among nurses and patients. We included 14 participants (n=6 nurses, n=8 patients) in three participating centres (Modena University Hospital, Italy; La Paz University Hospital Madrid, Spain; University Medical Center Utrecht, the Netherlands). Participants were asked to perform basic operational procedures with the device according to a usability task list. Their performance was observed and use errors were noted. Furthermore, participants were asked for feedback, both verbally and by means of completing the system usability scale (SUS), reflecting perceived usability on a scale from 0 (worst) to 100 (best). In total, 22 use errors occurred, 10 in nurses and 12 in patients. The mean SUS score was 70 (range 57.5 - 85) for nurses, and 71.9 (range 55 - 87.5) for patients. Despite the slightly above-average perceived usability of the device's current design stage, participants made a lot of suggestions for improvements, and indeed, usability must be improved to make the device ready for market introduction.
- Conditions
- Peritoneal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nurses | Nurses, aged 18 years or older, and having >1 years of professional experience with PD. | |
| Patients | Patients, aged 18 years or older, having a clinical diagnosis of ESRD and any treatment experience with PD, either current or in the past. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use errors
The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.
Measured: During the procedure (usability test)
Secondary outcomes (2)
Completion rate
The number and percentages of tasks successfully completed during task performance. Reported per participant and for the total group.
Measured: During the procedure (usability test)
Perceived usability
Participants' perceived usability of the device using the 10-item System Usability Scale (0-100 scale). Scores were reported per participant and for the total group.
Measured: Immediately after the procedure (usability test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Nov 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Azienda Unita' Sanitaria Locale Di Modena
- Responsible party
- Principal investigator, Karin G.F. Gerritsen, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131995
- Sponsor's protocol ID
- 21/616
- Acronym
- WEAKID
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy-sensitive information
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Usability Testing Study of a Novel Medical Device for Peritoneal Dialysis (WEAKID)
- ClinicalTrials.gov ID
- NCT07131995
- Acronym / sponsor ID
- WEAKID / 21/616
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Azienda Unita' Sanitaria Locale Di Modena
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 20 Aug 2025 (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.
This study aimed to formatively test the usability of the WEarable Artificial KIDney (WEAKID) for peritoneal dialysis (PD) in the device's intended user populations (i.e., nurses and patients).
Detailed description
End stage renal disease is a growing health problem worldwide, with a growing number of patients requiring a kidney transplantation. Recent years have seen the development of multiple novel devices for both hemodialysis and peritoneal dialysis (PD), one of these devices being the WEarable Artificial KIDney (WEAKID) for PD. WEAKID uses both sorbent technology and continuous flow PD to improve dialysis efficacy. Here, we present the results of a formative usability testing study of WEAKID among nurses and patients. We included 14 participants (n=6 nurses, n=8 patients) in three participating centres (Modena University Hospital, Italy; La Paz University Hospital Madrid, Spain; University Medical Center Utrecht, the Netherlands). Participants were asked to perform basic operational procedures with the device according to a usability task list. Their performance was observed and use errors were noted. Furthermore, participants were asked for feedback, both verbally and by means of completing the system usability scale (SUS), reflecting perceived usability on a scale from 0 (worst) to 100 (best). In total, 22 use errors occurred, 10 in nurses and 12 in patients. The mean SUS score was 70 (range 57.5 - 85) for nurses, and 71.9 (range 55 - 87.5) for patients. Despite the slightly above-average perceived usability of the device's current design stage, participants made a lot of suggestions for improvements, and indeed, usability must be improved to make the device ready for market introduction.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurses | – | –Nurses, aged 18 years or older, and having >1 years of professional experience with PD. |
| Patients | – | –Patients, aged 18 years or older, having a clinical diagnosis of ESRD and any treatment experience with PD, either current or in the past. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants represented two populations of intended users of the device, namely nurses and patients. The sample sizes were set at 6 (nurses) and 8 (patients). Prior work on the sample sizes of formative usability testing has shown that these sample sizes suffice to identify the most important design issues.
Key inclusion criteria (2 listed)
- Nurses: aged 18 years or older, >1 years of professional experience with PD.
- Patients: aged 18 years or older, clinical diagnosis of ESRD, any treatment experience with PD, either current or in the past.
Key exclusion criteria (2 listed)
- Nurses: none.
- Patients: severe physical and/or cognitive impairment, as judged by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Use errors
Time frame: During the procedure (usability test)
The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.
2 secondary outcomes
Completion rate
Time frame: During the procedure (usability test)
Perceived usability
Time frame: Immediately after the procedure (usability test)
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 27 Aug 2025.
- Individual participant dataSharing planned: No. Privacy-sensitive information
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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?
An observational study of Peritoneal Dialysis, run by UMC Utrecht at 1 site in Netherlands.
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 2 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 27 Aug 2025. 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 Netherlands. 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?
Use errors (time frame: During the procedure (usability test)). 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 27 Aug 2025.