We have invented and developed a safe, low cost device to undertake prostate biopsies that eliminates infections and sepsis risks and is ideally suited for local anaesthesia (LA) outpatient procedures.
The CAMbridge PROstate Biopsy DevicE – Simple, low-cost Local Anaesthetic Transperineal Prostate Biopsies through a simple coaxial access system
Prostate cancer is the commonest male malignancy and its incidence is set to rise in the next few decades. The diagnosis of cancer is most commonly based on a transrectal ultrasound guided biopsy of the prostate (TRUSBx) under local anaesthesia (LA). This method is economical, facilitates image-guided targeting and is ideally suited to the outpatient setting as it requires low amounts of local anaesthetic (LA). As a result, more than 80% of prostate biopsies are performed this way accounting for >1 million annual procedures in the western world alone.
The CAMbridge PROstate Biopsy DevicE – CamPROBE
TRUSBx are however associated with a significant risk of biopsy associated infection (up to 22%) and sepsis (up to 10%) because the needle has to repeatedly traverse the rectal wall.
Batura et al modelled the resource impact of post-biopsy sepsis in the NHS and estimated an annual cost burden of £7–11 million. Another major concern is the increasing incidence of prostate biopsy related antibiotic resistance.
Transperineal (TP) biopsies are much less risky but is more painful as the needles passes through perineal skin and pelvic-floor musculature hence usually necessitating a general anaesthetic or sedation. As a result, there has been a concerted effort by many clinicians to explore how this can be done under LA. Current options however are costly and still need significant amounts of LA infiltration
To address this, we developed the (the CAMbridge PROstate Biopsy DevicE – CamPROBE) based on the concept of a co-axial cannula, but designed specifically for transperineal prostate biopsies under LA (1). (UK patent GB1412726.0)
The CamPROBE is inserted at 2 points on either side of the perineum mid-line. It is then advanced to the prostate with simultaneous targeted LA infiltration to deeper structures (including pelvic muscles) using the integrated delivery needle and under transrectal ultrasound guidance.
Once in position, the needle is removed and the CamPROBE cannula can be used as an access sheath for prostate biopsies thus limiting tissue trauma and pain. The CamPROBE can be angled or repositioned to reach different areas without superficial or deep structure re-puncture.
In recent NIHR funded i4i trial we developed the device from a surgical steel prototype to a single-use disposable version. This was tested for its safety and performance in a multi-centre clinical evaluation.
The study showed that the device was safe (no infections), transferable, well tolerated by patients and easy to adopt. Moreover, cancer diagnosis rates were equivalent to other standard biopsy methods.
Images of its use and placement (see video for detailed description)
The CamPROBE is now being prepared for CE marking and is planned to be available by early 2022. Please contact Vincent Gnanapragasm for any enquiries via our Contact Form.
Papers & Publications
Thurtle D, Starling L, Leonard K, Stone T, Gnanapragasam VJ. Improving the safety and tolerability of local anaesthetic outpatient transperineal prostate biopsies: A pilot study of the CAMbridge PROstate Biopsy (CAMPROBE) method. J Clin Urol. 2018 May;11(3):192-199.
Multicentre clinical evaluation of the safety and performance of a simple transperineal access system for prostate biopsies for suspected prostate cancer: The CAMbridge PROstate Biopsy DevicE Vincent J Gnanapragasam, Kelly Leonard, Michal Sut, Cristian Ilie, Jonathan Ord, Jacques Roux, Maria Consuelo Hart Prieto, Anne Warren, Priya Tamer