Performance Evaluation of New 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

  288622

• Contact name

  Aaron Peace

• Contact email

  a.peace@c-tric.com

• Sponsor organisation

  Cirdan

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  1 years, 2 months, 12 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.
  Step 1
  Cirdan Solas unit is placed close to the standard imaging device (Faxitron BioVision):
  No patient data is required
  automatically capture multiple images of the same specimen at different KV and exposure settings – this will speed up the image acquisition process while acquiring a comprehensive image set for each specimen.

  Step 2
  For an agreed number of specimens
  NHS staff shall operate and acquire images of the specimen using their standard imaging device (Faxitron BioVision).
  Cirdan would also like to capture information regarding the usability of the Faxitron such as
  i.The time taken to initially calibrate the system
  ii.In use, the number of actions/clicks required to operate, and time taken to complete the imaging
  Immediately NHS staff shall then transfer the specimen to the Solas system. The desired outcome is to have a representative set of images from both the stand-of-care device and the Cirdan system to analyse and compare at a later time.

  Step 3
  Cirdan shall initially analyse images:
  To ensure they are properly corrected and reconstructed
  To record the settings (such as KV, exposure etc.) of the acquired images that are optimal for image quality

  Step 4
  A brief review of the image sets from each device involving Cirdan staff and a Radiologist to:
  form an opinion on the Solas performance compared with the Faxitron
  confirm the identify the best settings of the Solas unit
  ascertain if other changes are required such as post-processing.

• REC name

  West of Scotland REC 1

• REC reference

  20/WS/0158

• Date of REC Opinion

  5 Nov 2020

• REC opinion

  Unfavourable Opinion