Positive ADENOMA trial for EndoCuff Vision colonscopy device.

Norgine B.V. and its subsidiary Arc Medical Design Ltd highlighted the positive results of the new Accuracy of Detection using EndoCuff Optimisation of Mucosal Abnormalities (ADENOMA) multicentre randomised controlled trial comparing adenoma detection rate between EndoCuff Vision assisted colonoscopy (EAC) and standard colonoscopy (SC).

Adenoma detection rate is the most important marker of colonoscopy quality to help detect anomalies and colorectal cancer. The study is now published in the journal GUT.

The data show that EndoCuff Vision assisted colonoscopy increased adenoma detection rate globally but showed to be particularly effective in bowel screening patients as part of the UK Bowel Screening Programme (BCSP). The adenoma detection rate improvement was driven by the BCSP subgroup with a 10.8% increase (61.7% EndoCuff Vision vs. 50.9% standard colonoscopy) p<0.001. Equally, the increase in colorectal cancer detection with EndoCuff Vision assisted colonoscopy was in the screening patients (BCSP) subgroup (6.6% vs 3.7%, P=0.03). The authors state that overall, the study demonstrates that EndoCuff Vision is a safe device, which improves adenoma detection rate in patients with positive faecal blood tests. It speeds up procedures and is generally well tolerated by patients.

The study recruited 1772 patients (57% male, mean age 62 years) over 16 months with 45% recruited through screening. Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme (BCSP) were recruited from seven UK hospitals. Forty eight colonoscopists participated in the trial, of which 17 were Bowel Screening Programme colonoscopists.

Comment: EndoCuff Vision has a CE Mark and Olympus obtained 510(k) clearance from the FDA for its EndoCuff endoscopic device. The approval has been granted to improve adenoma detection rate (ADR) during colonoscopy over standard colonoscopy. The EndoCuff is the previous iteration of its recently launched EndoCuff Vision. Olympus Medical is the distributor of EndoCuff in the US and Canada.

See- Wee Sing Ngu, Roisin Bevan, Zacharias P Tsiamoulos, Paul Bassett, Zoë Hoare, Matthew D Rutter, Gayle Clifford, Nicola Totton, Thomas J Lee, Arvind Ramadas, John G Silcock, John Painter, Laura J Neilson, Brian P Saunders, Colin J Rees "Improved adenoma detection with EndoCuff Vision: the ADENOMA randomised controlled trial"- Gut Jan 2018, gutjnl-2017-314889; DOI: 10.1136/gutjnl-2017-314889.