Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04315129
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-03-18
Brief Title:
Smart Catheter A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Smart Catheter A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary Tract Infection UTI is the most common hospital acquired infection worldwide and is most commonly associated with catheterisation of the bladder Catheter associated urinary tract infection CAUTI causes increased hospital costs increased length of stay and increased mortality This burden of disease is in part mediated by a lack of diagnostic and monitoring modalities for CAUTI Both traditional and novel UTI diagnostic tests are susceptible to false positives associated with bacterial colonisation and correlate poorly with clinically meaningful symptomatic CAUTI As such the current standard of care is reliant on clinical monitoring which is susceptible to diagnostic delays over and under treatment
Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry This project aims to validate this biosensor and demonstrate its potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring
Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry This project aims to validate this biosensor and demonstrate its potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring
Detailed Description:
This research project aims to demonstrate that continuous urinary biochemical monitoring using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated urinary tract infection CAUTI The primary research question will then be Does the Smart Catheter device reduce the time to diagnosis of CAUTI
This will be accomplished through four studies The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement
The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question What is the difference in biochemical concentrations in healthy urine as compared to infected urine Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced
The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring
This will be accomplished through four studies The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement
The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question What is the difference in biochemical concentrations in healthy urine as compared to infected urine Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced
The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None