Clinical Trial Program

The clinical trial program has been a major feature of the flexible endomicroscope collaboration with Pentax.

Clinical trials play a critical role in the introduction of a new technology such as the endomicroscope. They serve to:

Provide clinician feedback on use and ergonomics
Identify and validate high potential clinical applications
Provide a useful independent assessment through ethics approvals
Capture data for analysis of clinical efficacy
Provide material for publication which is critical for raising doctor awareness and interest.

The flexible endomicroscopy clinical trial program commenced in 2003 at the Cabrini Hospital in Melbourne, and throughout the period has been significantly expanded by Pentax. It now spans four continents and leading teaching hospitals. Leading medical institutions involved in the international flexible endomicroscopy clinical trials have included:

Cabrini Hospital, Melbourne, Australia
Bankstown–Lidcombe Hospital, Sydney, NSW
Johannes Gutenberg University of Mainz, Mainz, Germany
Horst Schmidt Kliniken, Weisbaden, Germany Evangelisches Krankenhaus Dusseldorf, Dusseldorf, Germany
C.H.U. Poitiers- La Milétrie, France
Kyushu University Hospital, Fukuoka, Japan
Jikei University Hospital, Tokyo, Japan
Nagoya University Hospital, Nagoya, Japan
Chiba University Hospital, Chiba, Japan
Johns Hopkins University Hospital, Baltimore, USA
University of Pittsburgh Medical Centre, Pittsburgh, USA
Massachusetts General Hospital, Boston, USA
National University Hospital, Singapore
Singapore General Hospital, Singapore

In planning the trial program, Optiscan and Pentax, in consultation with leading gastroenterologists, continue to identify key areas of medical need where the flexible endo-microscope has high potential to improve outcomes and lead to substantial uptake of the technology:

Monitoring of inflammatory bowel disease (IBD), including ulcerative colitis
Surveillance for esophageal cancer in patients with Barrett’s oesophagus
Colon cancer surveillance
Diagnosis and surgical management of gastric cancer
Diagnosis and monitoring of gastritis and intestinal metaplasia
Detection of Helicobacter pylori
Surveillance for signs of organ rejection in small bowel transplant patients
Monitoring coeliac disease activity
Diagnosis of microscopic colitis
Diagnosis and monitoring of non-erosive reflux disease (NERD)

In scientific data made public during the year, clinical investigators reported extremely high sensitivity, specificity and accuracy outcomes for diagnosing neoplasias (very early cancers) in several clinical studies. Key trial results presented at Digestive Disease Week 2005, in Chicago, USA included:

Study focus	Number of patients	Sensitivity	Specificity	Accuracy
Neoplasia in Ulcerative Colitis	153	94.7%	98.3%	97.8%
Diagnosis of Barrett’s esophagus	42	98.8%	94.4%	97.5%
Neoplasia in Barrett’s esophagus	42	91.7%	99.0%	97.5%
Neoplasia in Screening Colonoscopy	27	97.4%	99.4%	99.2%
H. pylori diagnosis	12	100%	100%	100%

DDW is the world’s largest and most prestigious annual global meeting of gastroenterologists and flexible endoscope users and was the ideal high profile congress to release these extremely impressive trial results. Investigators presented additional data in Los Angeles at the DDW 2006 congress, further establishing the high diagnostic sensitivity, specificity and accuracy for diagnosing neoplasias (early cancers) through ongoing studies with expanded patient populations, plus identifying other new uses for endomicroscopy. In particular, Dr Ralf Kiesslich presented the results of his 153 patient randomised prospective blinded ulcerative colitis study in a DDW plenary session to an audience of over 4,000 doctors. Dr Kiesslich reported that confocal endomicroscopy could identify four times as much neoplasia (early cancerous change) than the standard care endoscopy procedure, with 1/10th the number of biopsies necessary.

Ulcerative Colitis patients	Conventional Endoscopy with random biopsy	Confocal Endomicroscopy with targeted biopsy
N=	73	80
Number of intraepithelial neoplasias (confirmed by biopsy)	4	19
Number of biopsies	42.2 per patient	21.2 per patient (total) 3.9 per patient (blind predicted as necessary for biopsy)

Results from the first studies at Cabrini Hospital (Melbourne, Australia) and Johannes Gutenberg University of Mainz (Mainz, Germany) demonstrating clinical utility and diagnostic efficacy of confocal endomicroscopy have been published in peer reviewed gastrointestinal medical journals and attracted very positive editorial comment.

Click here to review latest publications