Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000078752
Ethics application status
Approved
Date submitted
24/12/2021
Date registered
21/01/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Point of Care Peritoneal Dialysis System Early Evaluation Study
Scientific title
A Mixed Methods Early Evaluation Study To Assess The Safety, Efficacy and Usability Of A Point of Care Peritoneal Dialysis System When Used By Patients In The Home
Secondary ID [1] 306098 0
Nil
Universal Trial Number (UTN)
Trial acronym
POC-PDEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dialysis 324763 0
End Stage Kidney Disease 324764 0
Condition category
Condition code
Renal and Urogenital 322214 322214 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
POC-PDEE will utilise different methodologies to establish the safety, efficacy and usability of the Ellen Medical - Point of Care (EM-POC) peritoneal dialysis (PD) system with Australian dialysis patients. This study comprises three inter-linked components: (1) a series of human factors usability assessments, (2) a shadow study testing the reliability of the chemical composition and sterility of PD fluid produced by the EM-POC system when used by dialysis patients or their carers independently at the point-of-care and (3) semi-structured interviews to assess patient perspectives regarding the EM-POC system, it’s usability and the training provided prior to using the EM-POC system.

(1) Human Factors Assessment. A mixed methods study to collect observational and interview data from patient and clinician participants, who will be asked to complete specified tasks through simulated use testing, using: photographs, computer aided design (CAD) models, foam models and functional prototypes of the EM-POC system to identify potential human factors risk, use errors and possible improvements to the design of the system. The system prototypes used in these evaluations will not provide medical therapy. Assessments will be conducted individually with around 23 participants (approximately 20 patients and 3 clinicians) and will be conducted in patient participants’ homes or in the peritoneal dialysis unit. Assessments will be conducted by a human factors expert with over 20 years of experience in medical device product development and will last approximately 90 minutes.

(2) Shadow Study. An open label in-vitro interventional study to test the chemical composition and sterility of PD fluid produced by patient participants using the EM-POC system at home. EM-POC PD fluid will NOT be used for dialysis in any participants. Instead, five patient participants will prepare four bags of PD fluid each day for five days at home using the EM-POC system. The filled PD bags will be collected and sent for testing of chemical composition and sterility. Participants will be trained to use the EM-POC system by a peritoneal dialysis clinical nurse specialist. Adherence will be monitored by daily visits to participants’ homes and collection of filled dialysis bags.

(3) Patient Perspectives. A qualitative research study collecting data through semi-structured interviews from all five participants in the Shadow Study regarding their expectations, experiences and training with the EM-POC system. Daily participant experience will also be collected using a brief questionnaire. All interviews will be conducted via videoconference by an interviewer with extensive experience in qualitative research methods and patient partnership. Interviews will be recorded using videoconference software and transcribed to facilitate data analysis. Interviews will be conducted once with each participant, between one-three weeks following completion of the Shadow Study and take less than 60 minutes.
Intervention code [1] 322509 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329976 0
Usability of the EM-POC system and identification of human factors risk, use-related hazards and the effectiveness of training and risk control measures - assessed through participant observation, specifically designed pre-evaluation questionnaires and semi-structured interviews
Timepoint [1] 329976 0
Assessed during the human factors assessments and patient perspective semi-structured interviews during the study
Primary outcome [2] 329977 0
Chemical composition of the PD fluid created at the point of care (osmolality, pH, glucose, sodium, chloride, calcium, magnesium and bicarbonate concentrations will be measured for each bag of PD fluid filled)
Timepoint [2] 329977 0
Each bag of PD fluid filled by the participants will be collected the following day for 5 consecutive days and tested for chemical composition.
Primary outcome [3] 329978 0
Sterility of the PD fluid created at the point of care (samples will be tested from each bag of PD fluid for the presence of micro-organisms and endotoxin. If present, identification of micro-organisms will be performed and reported)
Timepoint [3] 329978 0
Each bag of PD fluid filled by the participants will be collected the following day for 5 consecutive days and tested for sterility.
Secondary outcome [1] 404494 0
The volume of delivered PD fluid will be measured by weight for each filled EM-POC PD fluid bag and any difference between the intended and delivered volume will be calculated.
Timepoint [1] 404494 0
Each bag of PD fluid filled by the participants will be collected the following day for 5 consecutive days and tested
Secondary outcome [2] 404495 0
Adverse event and device malfunction reporting, which could include any malfunction of the EM-POC system, PD bag or any reason that a participant is unable to continue using the EM-POC system. Assessment will be conducted using specifically designed questionnaires.
Timepoint [2] 404495 0
Assessment for adverse events and device malfunction will be conducted during the daily nurse visit to the participant's home. These visits will occur on each day of the 5-day study and following study completion.

Eligibility
Key inclusion criteria
Patient Participants:
1. Aged between 18 years and 80 years (inclusive);
2. Willing and able to participate in the study;
3. Treated with peritoneal dialysis for a minimum of 6 months (either automated peritoneal dialysis or continuous ambulatory peritoneal dialysis);
4. Able to speak sufficient English to be trained safely in the EM-POC dialysis system and understand the training materials;
5. Provide written informed consent;
6. At-home requirements: The participant’s home must have an electricity supply and a supply of potable water.
7. Received a full course of vaccinations against COVID-19 as per contemporary NSW Health advice

Clinician Participants:
1. Physicians or nursing staff with at least 12 months experience of PD
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient participants:
1. Expecting a planned procedure, dialysis modality change or transplant during the study;
2. Any condition or anticipated complication which in the opinion of the investigator would prevent compliance with study protocols or completion of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study comprises three inter-linked components, some participants will be enrolled in the Human Factors Assessments and some in the Shadow Study/Patient Perspective semi-structured interviews. Not all participants will be enrolled in all parts of the study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an early evaluation study to establish the safety, efficacy and usability of the EM-POC system with Australian dialysis patients.

For the Human Factors Assessments: A sample size of approximately eight participants has been selected for the first formative evaluation. With a sample size of eight participants, a usability problem with a pass rate of 60% or less will be detected with a high probability (at least 69%). The usability testing procedure follows the proposed "optimistic" ANSI/AAMI HE75:2009 approach. The pass rate is assumed to be acceptable unless the testing procedures show overwhelming evidence to the contrary.

For the Shadow Study and Patient Perspectives: A sample size of five participants, producing 100 bags for testing of chemical composition and sterility is felt to be sufficient to provide evidence that the EM-POC system can be used at the point-of-care by patients to produce PD fluid in this early evaluation study. All participants in the Shadow Study will be invited to provide insight into their expectations and experiences through the semi-structured interviews.

Statistical Analysis Plan for the Shadow Study:

Chemical composition: Sodium (mmol/L), chloride (mmol/L), calcium (mmol/L), magnesium (mmol/L), bicarbonate (mmol/L), glucose (mmol/L), pH and osmolality (mOmol/L) concentrations will be measured in the EM-POC PD fluid from each bag. The mean concentrations for each variable +/- standard deviation (SD) will be reported. Frequency distribution graphs for each variable will be plotted.

Sterility: Samples from the EM-POC PD fluid will be tested for the presence of micro-organisms and endotoxin from each filled PD bag. Where micro-organisms are present, identification will be performed and reported. The number and proportion of bags with any detected microbial growth will be reported. Details of bacterial colonization, including identification of bacteria and number of CFUs will be reported. The number and proportion of bags with endotoxin >0.05IU/mL will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
29/06/2022
Date of last participant enrolment
Anticipated
31/01/2023
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
28
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21393 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21394 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 36283 0
2050 - Camperdown
Recruitment postcode(s) [2] 36284 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 310441 0
Commercial sector/Industry
Name [1] 310441 0
Ellen Medical Devices Pty Ltd
Country [1] 310441 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ellen Medical Devices Pty Ltd
Address
Level 5, 1 King Street,
Newtown
NSW
2042
Country
Australia
Secondary sponsor category [1] 311595 0
None
Name [1] 311595 0
Address [1] 311595 0
Country [1] 311595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310080 0
Sydney Local Health District Human Research Ethics Committee - CRGH
Ethics committee address [1] 310080 0
Ethics committee country [1] 310080 0
Australia
Date submitted for ethics approval [1] 310080 0
14/08/2020
Approval date [1] 310080 0
12/11/2020
Ethics approval number [1] 310080 0
CH62/6/2020-149

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116410 0
Prof John Knight
Address 116410 0
Ellen Medical Devices Pty Ltd
Level 5/1 King Street,
Newtown
NSW
2042
Country 116410 0
Australia
Phone 116410 0
+61 414 614 189
Fax 116410 0
Email 116410 0
[email protected]
Contact person for public queries
Name 116411 0
John Knight
Address 116411 0
Ellen Medical Devices Pty Ltd
Level 5/1 King Street,
Newtown
NSW
2042
Country 116411 0
Australia
Phone 116411 0
+61 2 8052 4300
Fax 116411 0
Email 116411 0
[email protected]
Contact person for scientific queries
Name 116412 0
John Knight
Address 116412 0
Ellen Medical Devices Pty Ltd
Level 5/1 King Street,
Newtown
NSW
2042
Country 116412 0
Australia
Phone 116412 0
+61 2 8052 4300
Fax 116412 0
Email 116412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregated, anonymised data will be available for this study, individual participant data will not be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.