Clinical proof of concept of PDMSD product (v.1.0)
Research type
Research Study
Full title
Clinical proof of concept and commercial PDMSD product development
IRAS ID
182913
Contact name
Nishal Govindji-Bhatt
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
The Peritoneal Device Microbial Sensing Device (PDMSD) is a point-of-care device able to signal the presence of clinically relevant levels of infection in waste peritoneal dialysis fluid through simple colour changes in a readout window. PDMSDs would act as an early warning system for peritonitis, replacing the current ambiguity and risk-prone self-monitoring of effluent cloudiness by patients. This will signal an emerging infection at an earlier stage than is currently possible. We believe that PDMSDs have the potential to improve outcomes for patients and extend the useful lifespan of PD therapy, which must often be abandoned due to recurrent infection problems. 100 ex vivo effluent samples from 10-50 patients will be required for this phase of the research, which will be tested with the PDMSD in vitro to provide the first clinical validation for the PDMSD and supporting safety of the device (specifically demonstrating the device does not produce false negatives or false positives with real clinical effluent).
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0641
Date of REC Opinion
1 Oct 2015
REC opinion
Further Information Favourable Opinion