AMSTERDAM, Netherlands, January 30, 2018 /PRNewswire/ --
- ENDOCUFF VISION®increased adenoma detection rate globally from 36.2% to 40.9% (P=0.02)[i]
- A total of 56 colorectal cancers were detected in 36 patients when using ENDOCUFF VISION® and in 20 patients during standard colonoscopy[i]
Norgine B.V. and its subsidiary Arc Medical Design Ltd highlighted today 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.
ENDOCUFF VISION® is a single use device attached at the end of the colonoscope that gives an optimal view of the entire colon by retracting folds during withdrawal.
The data shows 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).[i]
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.
Dr Colin Rees, Consultant Gastroenterologist, UK said: "This large multi-centre randomised controlled trial demonstrated a significant improvement in adenoma detection rate. "This rise was driven by faecal occult blood test positive screening patients where a 10.8% increase in adenoma detection rate was seen. ENDOCUFF VISION® should be considered to improve adenoma detection particularly in this population."
Dr Alastair Benbow at Norgine said: "We welcome the robust results of the ADENOMA study which demonstrate that ENDOCUFF VISION® clearly improves the quality of colonoscopy and the detection of colorectal cancer. ENDOCUFF VISION® should be used routinely for colorectal cancer prevention in order to reduce mortality and costs to healthcare systems."
Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with 447,000 new diagnoses every year.[ii]
In Europe, ENDOCUFF VISION® is available through Norgine and in other parts of the world the product is available through business partners. Norgine owns a majority stake of Arc Medical Desgin Ltd, the originator of ENDOCUFF VISION®.
Norgine and Arc Medical Design contributed to the funding of the ADENOMA investigator led study.
Notes to Editors:
About ENDOCUFF VISION®
To find out more about the product, go to http://www.endocuffvision.eu/
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine's total revenue was EUR 368 million. Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit http://www.norgine.com
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit http://www.norgineventures.com .
NORGINE and the sail logo are trademarks of the Norgine group of companies.
ENDOCUFF VISION is a registered trademark of Arc Medical Design Ltd.
i. Ngu WS, et al. Gut 2018;66:1-9. doi:10.1136/gutjnl-2017-314889
ii. Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012
Isabelle Jouin, T: +44(0)1895-453-643
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SOURCE Norgine B.V.