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Clinical Evaluation of the Nova Max Pro StatSensor Device

NCT07392710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-06

No results posted yet for this study

Summary

Blood creatinine is an important biomarker used to monitor kidney function. In patients with chronic kidney disease or patients who have received a kidney transplant, careful and frequent monitoring of kidney function is required to enable timely intervention in the event of deteriorating kidney function. Indeed, following kidney transplantation, patients may have their blood serum creatinine checked on average 20 times, during the first year post-transplantation to monitor for graft rejection.

In current clinical practice, most blood creatinine assessments (blood tests) are undertaken in the primary care GP clinics or hospital settings. This practice places burden on healthcare resources and may delay the early detection of deteriorating kidney function. It also places additional burden on patients and impact's their lives as patients are required to attend frequent clinic appointments and undertake regular blood tests. Therefore, the ability for individuals to remotely self-monitor their own kidney function would have a number of health and socio-economic related benefits.

Currently the study will evaluate the clinical usefulness and reliability of a handheld point of care creatinine monitoring device called the Nova Max Pro StatSensor device, in patients who have recently received a kidney transplant. The aim is to compare the clinical performance (i.e accuracy and precision) of the device, with standard laboratory based measurements for measuring blood creatinine levels, in 100 transplant patients attending the outpatient clinic. All patients will be enrolled in the study for a period of 12-weeks. As part of the nested sub-study, 30 participants will measuring their creatinine levels using the Nova Max Pro StatSensor device at home, on the morning of their outpatient clinic. the study will assess the patients experience and attitude towards using the device via a questionnaire and structured interview at the end of the study.

Conditions

  • Kidney Transplant
  • Kidney Disease, Chronic

Interventions

DEVICE

Nova Max Pro StatSensor device

The Nova Max Pro StatSensor creatinine analyser is a handheld device used for the quantitative measurement of creatinine in capillary, venous and arterial blood. This study will evaluate the Nova Max Pro in the outpatient setting to ascertain whether the device can be used to reliably monitor renal function remotely post-transplantation.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Royal Free Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Mark Harber, Dr · Royal Free London NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2024-12-12
Completion
2024-12-12

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392710 on ClinicalTrials.gov