Clinical Applications and Trials

Gastroenterology Clinical Trials

Optiscan is currently assisting in two multicentre trials for the application of the technology in gastroenterology.


The European multi-centre trial supported by Hoya began in April 2008 and draws 200 cases from hospitals in Germany, Italy and England.  It is scheduled for completion in 2009.


The trial is focussed on Ulcerative Coilitis and in keeping with world health organisation guidelines the trial has been registered.  Details can be found at www.clinicaltrials.gov using trial reference number NCT00659867.


A multicentre trial in the US led by Dr. Marcia Canto from Johns Hopkins Hospital (Baltimore, MD, USA), has received funding from the American Society for Gastrintestinal Endoscopy (ASGE). Other hospitals participating in the study include the Cleveland Clinic (Cleveland, OH, USA), Massachussetts General Hospital (Boston, MA, USA), Mount Sinai Medical Center (New York, NY, USA) and the University of Mainz (Mainz, Germany). This independent endorsement by a major US learned society reflects the importance of the technique and its potential to address a major area of need in endoscopy for Barrett’s esophagus. The multi-centre nature of the trial and its randomised controlled design is expected to produce a weight of medical evidence sufficient to influence practice guidelines. This would be a major stimulus to uptake of the technology.  The trial is expected to start recruitment of patients late in 2009.

Details of some of the clinical trial sites, investigators, research areas and results are reported at www.endomicroscopy.org.


The potential applications for the technology in gastroenterology include:

  • Ulcerative Colitis – surveillance for neoplasia in inflammatory bowel disease
  • Diagnosis of neoplasia during screening colonoscopy
  • Barrett’s Esophagus – diagnosis, surveillance for neoplasia and management
  • FAP – sampling multiple polyps in polyposis syndrome patients
  • Coeliac disease – monitoring disease activity and histological change in gluten intolerant patients
  • Identification of Helicobacter pylori in the gastric mucosa (cause of ulcers and cancer)
  • Gastric cancer – diagnosis of stomach cancer and margin assessment
  • Flat adenomas and aberrant crypt foci – progression to colorectal cancer
  • Small bowel transplants – monitoring for rejection
  • Non-erosive reflux disease (NERD) - diagnosis of esophageal inflammation not evident on endoscopic examination
  • Microscopic colitis - inflammatory condition diagnosis, often missed by conventional biopsy
  • Gastric intestinal metaplasia - monitoring transformation of the stomach lining that can lead to cancer

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