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CompletedNCT04137315Updated Feb 9, 2021

Project Aura: Home Trial of a Home-based Monitoring Service

An observational study in Chronic Kidney Diseases, sponsored by Entia Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Entia Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

This is a data collection study to compare diagnostic methods of a prototype of a home monitoring device against laboratory testing in the hospital.

Read the detailed description

The device/monitoring system being developed measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor their haemoglobin level at home.

The use of the device will take place in the participant's home to simulate what the investigators believe will be the ideal location for people who would prefer to self-manage their condition.

This study is a data collection study to evaluate the performance of the prototype.

02

Conditions studied

  • Chronic Kidney Diseases
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 10 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Entia Ltd is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The participants will be recruited from the study site.

Inclusion criteria

  • Age ≥ 18 years of age.
  • Adequate english to participate in training sessions and use the analyser.
  • Patients of the study site who are currently undergoing treatment for anaemia of CKD with ESAs.
  • Patients who are not pregnant.
  • Patients who do not have a bleeding disorder.
  • Patients willing to perform self-tests 2-3 times a week.
  • Patients capable of providing informed consent before attending training.
  • Patients or patients with a carer capable of fine manipulation of the device and its consumables.
  • Patients or patients with a carer who own a smartphone which can download the app related to this study.
  • Patients or patients with carers who do not have eyesight limitations to be able to read the instructions on the screen of the prototype device.
  • Patients who are not expected to have to start dialysis treatment during the course of this study.

Exclusion criteria

Exclusion Criteria:

  • Does not have adequate English to participate in training or use the analyser without an interpreter.
  • Patients of the study site who are not currently undergoing anaemia treatment with ESAs.
  • Patients of the study site not willing to perform self-tests 2-3 times a week.
  • Patients of the study site not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the trial.
  • Patients who are pregnant.
  • Patients with a bleeding disorder.
  • Patients or their nominated carers who are not capable of fine manipulation of the device and its consumables.
  • Neither patients or their nominated carers do not own a smartphone which can install the app related to this study.
  • Patients or their nominated carers with eyesight limitations to not be able to read the instructions on the screen of the prototype device.
  • Patients who are expected to start dialysis treatment during the study.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No

Interventions

  • DeviceBlood measurement

    Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.

06

What researchers measure

Primary outcomes

  1. Quantitative capture of measurement system

    Data collection for evaluation of measurement system

    Time frame: 6 months

07

Study locations

1 site
  • Hull University Teaching Hospitals NHS Trust
    Hull, HU3 2JZ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — Study data will be pseudonymous (shared with the research \& clinical team). Participant data is only seen by the research nurse for contacting, updating and travel reimbursement purposes.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04137315
Lead sponsor
Entia Ltd
Responsible party
Sponsor
First posted
Oct 24, 2019
Start date
Feb 14, 2020
Primary completion
Jan 29, 2021
Completion
Jan 29, 2021
Last update
Feb 9, 2021

Study contacts

Sunil Bhandari, FHEA
principal investigator · Hull University Teaching Hospitals NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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