INNOVAT ION
procedure under LA in an outpatient setting. There are now other devices available on market that are capable of taking biopsies via the transperineal route. However, the CamProbe total free-hand device is also low cost.
The design and development The CamProbe is a coaxial, cannulated transperineal access system. The design features an integrated needle to which a standard syringe can be attached for LA delivery and the cannula is long enough to penetrate from the perineal skin into the prostate. This sheathed, coaxial cannula design means that biopsies can be carried out under LA by a single operator with one assistant. Furthermore, as the device can be inserted at the same time as LA infiltration, there is no need for additional nerve blocks or sedation. Once the patient is in the required position, a standard 18G core-needle biopsies can be undertaken through the retained cannula, under the guide of an ultrasound probe. A video showing the device in action can be viewed on YouTube at:
https://www.youtube.com/ watch?v=NxCPv8Z7GU8. The first generation of CamProbe was designed and manufactured by specialist engineers within the Clinical Engineering Innovation team at Cambridge University Hospitals NHS Foundation Trust. This team ensured the design and manufacture met the requirements of the Medical Devices Directive for in-house manufactured devices. Once efficacy was shown, and with specialist support from Health Enterprise East (HEE) on management of the intellectual property portfolio and commercial aspects of the device, further development was funded through an NIHR i4i (Invention for Innovation) award with JEB Technologies taking on the role of the development partner.
Clinical study To demonstrate the potential benefits CamProbe has to offer, a multi-centre clinical evaluation was set up. The main goal was to assess the safety and performance of the CamProbe system when carrying out prostate biopsies for suspected prostate cancers cases.
The study used disposable single-use
CamProbe devices that were manufactured based on a previous prototype. The CamProbe was offered as an alternative to transrectal ultrasound guided biopsy for men that were due to receive a prostate biopsy as part of their clinical management. Data on the following key parameters were recorded: l Safety, including infections and device performance
l Clinical utility l Reported patient experience l Biopsy quality l Cancer detection
The clinical benefits
A total of 40 patients were recruited into the study with a median age of 69 years. Six NHS sites were involved in the study, of which five sites were entirely new to the procedure. Overall, out of the 40 patients, 19 were first prostate biopsies and 21 were repeat procedures. The major finding was there were no infections, device deficiencies or safety issues reported. In addition to this, the procedure was well tolerated with excellent patient-reported perception and low pain scores, and the quality of the biopsy samples gained for histopathological analysis was also good. The overall cancer diagnosis rate for those having a first diagnostic procedure was 68% (13/19) and for significant cancers 47% (9/19). In addition to the clinical results, it was also important to note the time taken to undertake the procedure. The lead and most experienced centre completed the procedure in an average of 25 minutes.
Sagittal and Axial diagrams showing 18G biopsy needle introduced through the CamProbe cannula to take biopsies.
Lithotomy position
Sagittal diagrams demonstrating CamProbe insertion under US guidance with synchronous LA infiltration.
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WWW.CLINICALSERVICESJOURNAL.COM FEBRUARY 2021
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