Performance Evaluation of X-Ray Cabinet - The Cirdan Solas
Research type
Research Study
Full title
Intraoperative Imaging - Performance Evaluation of the Cirdan Solas against a currently used x-ray device
IRAS ID
292192
Contact name
Aaron Peace
Contact email
Sponsor organisation
Cirdan
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The following proposal shall be used to determine the quality of the Cirdan Solas compared with the leading competitor product for the examination of surgical breast specimens.
NOTE: The proposed protocol shall minimise disruption to the normal procedure and workflow for the intraoperative examination of lumpectomies since the specimen will be imaged in the standard device first thus providing the surgeon with information on the specimen as normal. Only after this is achieved will the specimen be imaged in the Cirdan system.1. Identify eligible participants through Principal Investigator
2. Give out participant Information Sheet/Study Invitation Letter to eligible participants prior to of their lumpectomy procedure
3. PI/Research team member to take consent from eligible and willing participants
4. PI/Clinician to obtain samples and image as per standard procedure for lumpectomy imaging
5. Post standard of care, the imaging sample is placed into Solas (outside of main theatre for patient privacy) and imaged in-conjunction with Cirdan staff for operability of Solas.
6. Copy of Faxitron and Solas images are used for comparison purposes (with patient identifiable data removed), image comparison of Solas image to the Faxitron image will be carried out by CI/PI and results passed to Cirdan staff (non—identifiable information)Once 20 participants and their samples have been processed as per above. The PI/clinician will give a report on image comparison and operability/professional opinion of Solas machine and a report will be written and signed off by CI and given to Cirdan, thus concluding the study.
REC name
Wales REC 6
REC reference
21/WA/0054
Date of REC Opinion
12 Mar 2021
REC opinion
Further Information Favourable Opinion