PARIS, Dec. 15, 2008 (GLOBE NEWSWIRE) -- Doctors in the U.S. and Germany have enrolled the first patients in an international, multi-center study designed to add to the growing body of clinical evidence that shows that Cellvizio(r), the world's smallest microscope, helps physicians confirm if Barrett's Esophagus has progressed so they can treat the dysplastic or cancerous condition immediately with fewer biopsies.
"Until now, we haven't been able to differentiate dysplastic and cancerous tissue within the Barrett's segment, so we take random biopsies from the area in hopes that this will represent an accurate sample," said Prateek Sharma, MD, Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Kansas School of Medicine and the Veteran Affairs Medical Center, Kansas City, Missouri, USA and the trial's principal investigator. "With this study, we hope to confirm that viewing Barrett's tissue at the cellular level with the Cellvizio miniprobe increases our ability to identify and immediately remove abnormal tissue without as many biopsies."
Columbia-Presbyterian Medical Center in New York City, the Veteran Affairs Hospital in Kansas City, Mayo Clinic in Jacksonville, Florida and Klinikum rechts der Isar in Munich, Germany plan to enroll more than 100 patients in the study, known as DONT BIOPCE (Detection Of Neoplastic Tissue in Barrett's Esophagus with In vivO Probe-based Confocal Endomicroscopy).
"We hope to reproduce the positive results of our earlier Barrett's Esophagus studies in a wider group of physicians and patients," explained Sacha Loiseau, president, CEO and founder of Mauna Kea Technologies, the company that developed Cellvizio. "We believe this new study will help underscore the impact that more accurate biopsy targeting can have on therapeutic patient management, improved patient care and efficiency within the hospital."
Barrett's Esophagus occurs when gastroesophageal reflux disease causes stomach acid to leak back into the esophagus and damage the lining. This can increase the risk of cancer of the esophagus (adenocarcinoma), the symptoms of which can be difficulty swallowing or weight loss. Since the 1980s, incidence rates of adenocarcinoma of esophagus (ACE) have been increasing in both genders in developed countries. ACE is the fastest rising malignancy among white men in the United States, with a relative increase even higher than that observed for breast cancer, malignant melanoma, or prostate cancer. From 1975 to 2001, the incidence of ACE increased sixfold in the United States, from 4 to 23 cases per million (Journal of the National Cancer Institute 2005;97:142-146).
Details of the study can be found on www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT00795184).
About Cellvizio(r)
Cellvizio(r), the world's smallest microscope, is the first system designed to provide live images of internal human tissues at the cellular level during endoscopic procedures. This new method, known as probe-based confocal laser endomicroscopy (pCLE), allows physicians to pinpoint and remove diseased tissue with endoscopic tools on the spot, or, in more serious cases, send the patient directly to surgery. This new, advanced imaging technique helps physicians more effectively detect cancer so patients can be treated earlier and undergo fewer biopsies. Physicians and thought leaders at more than 40 top medical institutions around the world have completed over 2,000 of these procedures and have published more than 25 peer-reviewed papers on the technology in major medical journals. Cellvizio, which delivers up to 12 images per second and can be used with almost any endoscope, has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the gastrointestinal and pulmonary tracts.
About Mauna Kea Technologies/Cellvizio Inc.
Mauna Kea Technologies, which operates as Cellvizio Inc. in the U.S., is a venture-backed medical device company based in Paris, France, with U.S. offices in Fort Washington, Penn. With its flagship Cellvizio(r) system, the company leads the growing in vivo cellular imaging market, enabling physicians to visualize, diagnose and treat pathologies that cannot be seen using other imaging techniques. Investors include Psilos Group, Seventure and Creadev. For more information about Mauna Kea Technologies: www.maunakeatech.com