End Stage Renal Failure on DialysisNCT04292210
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
A study testing Perisafe in people with End Stage Renal Failure on Dialysis and End Stage Renal Disease on Dialysis, run by Peripal AG at 1 site in United Kingdom.
Trial summary
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure
- What is being tested?
- Perisafe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2018to 30 Apr 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Fifteen patients and nine carers volunteered in this study, ranging from 23 to 86 years in age and from 0.3 to 24 years in experience in the PD therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Trauma Management MedTech Co-operative
Birmingham
About this study
Official title: Evaluating Patient Safety And Ease Of Use Of A Novel Connection-Assist Device For Peritoneal Dialysis
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.
Read the detailed description
The growth in the renal replacement therapy population is primaryly in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed.
As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.
The evaluated device is designed to assist peritoneal dialysis patients performing their daily dialysis treatment either for APD or for CAPD. The device facilitates the connection and disconnection of the dialysis line to the PD catheter transfer set. The connections are performed inside the device in a protected area, and the patient does not need to touch the transfer set or the dialysis line while they are unprotected. In addition, the breaking of the dialysis line frangible and the clamping of the dialysis line are replaced by pushing a button.
The operating procedure of the device consists of multiple tasks including preparing and loading the transfer set and dialysis line into the device, performing the handling steps related to the PD therapy with the device and finally unloading the used material from the device. Each task comprises several handling steps. During the study, the operating procedure with the device was simulated and the subjects were connected to a dummy catheter, which was attached to an apron.
This study recruited established PD patients and carers involved in the delivery of PD. Carers included healthcare professionals and lay carers.
The study design was divided into three one hour long parts. Firstly, a training session introduced the operation of the device. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual.
The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. After the break, the subjects were asked to carry out a complete handling cycle themselves. Subjects could use the quick start guide and the device manual as help. After the unsupported handling cycle, subjects were asked to complete the NASA Task Load Index (N-TLX) questionnaire. In the meantime, the moderator left the room to obtain information on observed use errors. In a final semi-structured interview, the subjects were asked about the reasons for the observed use errors.
For each subject, one moderator and one observer were involved in the study. The moderator was the interface between the subject and the device both in training and in testing. This person was employed by an external agency to avoid any influence on the subject. The observer saw the handling with the help of a live feed from a separate room. He evaluated the handling steps in the categories of "safe use" and "use error" according to IEC 62366-1. For each use error, the observer described the observed situation from his point of view. In addition to evaluating the effectiveness of the task performance, the subjects were interviewed in a semi structured way. Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.
In addition, the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. To classify the results of the N-TLX, Eitrheim and Fernandes (2016) state "Workload levels below 50 were perceived as acceptable."
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis, Renal Replacement Therapy
- Being tested
- Perisafe
- Keywords
- patient safety, usability study, connection-assist device, ease of use, peritoneal dialysis, NASA Task Load Index, renal replacement therapy
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerisafeDevice
A medical device simplifying the connection of tubing as well as breaking of the frangible which is done in a sterile environment with the help of levers and buttons.
| Study group | Role | What they receive |
|---|---|---|
| CAPD handling | Experimental | A connecting device simplifying the steps during a cycle of Peritoneal dialysis. Instead of directly doing a manual connection and manually breaking a frangible, the device assist in connecting and breaking the frangible.
This study was done demonstrating a continuous ambulatory peritoneal dialysis (CAPD) Receives: Device: Perisafe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and ease of use of a connection device during a continuous ambulatory peritoneal dialysis
Firstly, a training session introduced the operation of the device. The normal steps of a manual connection and breaking of the frangible is replaced by the levers and the buttons in the device. The connections are thereby done in a 'safe' environment which reduces infection risk. A whole cycle of continuous ambulatory peritoneal dialysis is simulated during each training. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual.
The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device.
Each of the 24 subjects performed 52 handling steps resulting in a total of 1248 evaluated handling steps.
Measured: 3 hours
Nasa Task Load Index (N-TLX)
The operating procedure of the device consists of multiple tasks comprising several handling steps. the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. Workload levels below 50 were perceived as acceptable.
Measured: 3 hours
Observation of technique
Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.
Measured: 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start19 Feb 2018
- Primary completion12 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The growth in the RRT population is primary in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. It is proposed that by making PD treatment simpler, more standardized and better protected from infections, patient access to PD could be increased significantly. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed. As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peripal AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss Federal Institute of Technology, University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lukas Foggensteiner, MD, PhD, Study chair, National Health Service, United KingdomMirko Meboldt, PhD, Study chair, ETHMartin Dubach, Study chair, Peripal AGStephan Hess, Principal investigator, ETH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292210
- Sponsor's protocol ID
- IRAS ID :235715
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Safety And Ease Of Use Of A Novel Connection-Assist Device For Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT04292210
- Acronym / sponsor ID
- IRAS ID :235715
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis, Renal Replacement Therapy
- Keywords
- patient safety, usability study, connection-assist device, ease of use, peritoneal dialysis, NASA Task Load Index, renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peripal AGIndustry (pharma, biotech, devices)
- Collaborators
- Swiss Federal Institute of Technology, University Hospital Birmingham NHS Foundation Trust
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Mar 2020 (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.
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.
Detailed description
The growth in the renal replacement therapy population is primaryly in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed.
As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.
The evaluated device is designed to assist peritoneal dialysis patients performing their daily dialysis treatment either for APD or for CAPD. The device facilitates the connection and disconnection of the dialysis line to the PD catheter transfer set. The connections are performed inside the device in a protected area, and the patient does not need to touch the transfer set or the dialysis line while they are unprotected. In addition, the breaking of the dialysis line frangible and the clamping of the dialysis line are replaced by pushing a button.
The operating procedure of the device consists of multiple tasks including preparing and loading the transfer set and dialysis line into the device, performing the handling steps related to the PD therapy with the device and finally unloading the used material from the device. Each task comprises several handling steps. During the study, the operating procedure with the device was simulated and the subjects were connected to a dummy catheter, which was attached to an apron.
This study recruited established PD patients and carers involved in the delivery of PD. Carers included healthcare professionals and lay carers.
The study design was divided into three one hour long parts. Firstly, a training session introduced the operation of the device. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual.
The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. After the break, the subjects were asked to carry out a complete handling cycle themselves. Subjects could use the quick start guide and the device manual as help. After the unsupported handling cycle, subjects were asked to complete the NASA Task Load Index (N-TLX) questionnaire. In the meantime, the moderator left the room to obtain information on observed use errors. In a final semi-structured interview, the subjects were asked about the reasons for the observed use errors.
For each subject, one moderator and one observer were involved in the study. The moderator was the interface between the subject and the device both in training and in testing. This person was employed by an external agency to avoid any influence on the subject. The observer saw the handling with the help of a live feed from a separate room. He evaluated the handling steps in the categories of "safe use" and "use error" according to IEC 62366-1. For each use error, the observer described the observed situation from his point of view. In addition to evaluating the effectiveness of the task performance, the subjects were interviewed in a semi structured way. Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.
In addition, the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. To classify the results of the N-TLX, Eitrheim and Fernandes (2016) state "Workload levels below 50 were perceived as acceptable."
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The growth in the RRT population is primary in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. It is proposed that by making PD treatment simpler, more standardized and better protected from infections, patient access to PD could be increased significantly. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed. As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.
| Arm | Type | Receives |
|---|---|---|
| CAPD handling | Experimental | Device: PerisafeA connecting device simplifying the steps during a cycle of Peritoneal dialysis. Instead of directly doing a manual connection and manually breaking a frangible, the device assist in connecting and breaking the frangible. This study was done demonstrating a continuous ambulatory peritoneal dialysis (CAPD) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PerisafeA medical device simplifying the connection of tubing as well as breaking of the frangible which is done in a sterile environment with the help of levers and buttons. | Device | CAPD handling |
Primary outcome
Safety and ease of use of a connection device during a continuous ambulatory peritoneal dialysis
Time frame: 3 hours
Firstly, a training session introduced the operation of the device. The normal steps of a manual connection and breaking of the frangible is replaced by the levers and the buttons in the device. The connections are thereby done in a 'safe' environment which reduces infection risk. A whole cycle of continuous ambulatory peritoneal dialysis is simulated during each training. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual. The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. Each of the 24 subjects performed 52 handling steps resulting in a total of 1248 evaluated handling steps.
Nasa Task Load Index (N-TLX)
Time frame: 3 hours
The operating procedure of the device consists of multiple tasks comprising several handling steps. the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. Workload levels below 50 were perceived as acceptable.
Observation of technique
Time frame: 3 hours.
Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.
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 3 Mar 2020.
- Evaluating Patient Safety and Ease of use of a Novel Connection-Assist Device for Peritoneal DialysisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lukas Foggensteiner, MD, PhD study chair
National Health Service, United Kingdom
Mirko Meboldt, PhD study chair
ETH
Martin Dubach study chair
Peripal AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perisafe in people with End Stage Renal Failure on Dialysis and End Stage Renal Disease on Dialysis, run by Peripal AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. 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 United Kingdom. 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?
Safety and ease of use of a connection device during a continuous ambulatory peritoneal dialysis (time frame: 3 hours). The study lists 3 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 3 Mar 2020.