A comparative study of core biopsy x-ray devices
Research type
Research Study
Full title
Comparative study of a novel core biopsy x-ray device against a currently used x-ray device.
IRAS ID
226180
Contact name
Aaron Peace
Contact email
Sponsor organisation
Cirdan Imaging Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 5 days
Research summary
Comparative study of a novel core biopsy x-ray device against a currently used x-ray device.
This device is at the very early stages of development and is seeking proof-of-concept with a clinician before any further development.
Historical breast core biopsies will be chosen and anonymized by Dr. Iain Cameron, Pathology Department, Altnagelvin Hospital. These biopsies will then be imaged using the two x-ray devices. The images will then be evaluated by Dr. M., Reilly Consultant Radiologist. We will the provide a report on the images obtained from each device.
The sponsor has sought clarity from the MHRA on this early development study using limited tissue samples. The MHRA has confirmed that notification to MHRA is not required at this stage.
REC name
HSC REC A
REC reference
17/NI/0079
Date of REC Opinion
25 Apr 2017
REC opinion
Favourable Opinion