Evaluation Process For A Novel Disposable Cell Collection Device
Research type
Research Study
Full title
Evaluation process for the effectiveness, reliability and reproducibility of a Disposable cell collection Device (DCCD)
IRAS ID
178450
Contact name
Mr Kuchibhotla Satchi Swami
Contact email
Sponsor organisation
Cytosystems Ltd
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study has been designed as part of the evaluation process for the effectiveness, reliability and reproducibility of a novel disposable device for the isolation and collection of urinary epithelial cells released from the bladder. This device will form part of a diagnostic test for determining the presence or otherwise of urothelial carcinoma in man. To date, the detection of this cancer using standard cytological preparations has proved costly and time consuming for both laboratory, scientific and medical staff.
The rationale therefore is to develop a disposable device which can separate out bladder epithelial cells using specifically selected membranes in a closed pump arrangement. Such a device would isolate and preserve the cells immediately after void and these would then be sent to a pathology laboratory for analysis. The quality of cellular preservation is critical to the test to allow integrated analysis of cell morphology with the biomarker.
REC name
North of Scotland Research Ethics Committee 1
REC reference
15/NS/0038
Date of REC Opinion
16 Jun 2015
REC opinion
Further Information Favourable Opinion