NCT05962944

Remote Rapid Onsite Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)

Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Royal Cornwall Hospitals Trust · Academic / Other
• Sex: All
• Age: 18 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or Biomedical Scientist is a real time morphological assessment of the sample in the clinical setting with the aim of acquiring all the diagnostic material in one appointment resulting in reduction in costs, improved patient care and reduced referral to treatment time. It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.

Detailed description

The new faster diagnostic standards (FDS) alongside NICE guidance and the British association of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all FNA's. It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed. A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope in the ultrasound room. Using the Olympus software Cellsens and the screen share option in Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the sample in real time and provide both verbal and written methods of communication (relevant clinical information and instructions). An additional camera will allow visualisation of the slide preparation and residual material in real time to the scientist / pathologist performing the assessment. This study will investigate whether ROSE can be performed remotely. This study will be based in the cytology department at the Royal Cornwall Hospital as part of a service improvement. Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site. Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented for remote ROSE to be performed over a 12-month period.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DEVICE	Olympus Cellsens software	Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-06-15
• Completion: 2023-07-24
• First posted: 2023-07-27
• Last updated: 2023-08-01

Locations

1 site across 1 country: United Kingdom