PARIS, Oct. 19, 2009 (GLOBE NEWSWIRE) -- Mauna Kea Technologies announced today completion of enrollment for two company-sponsored multi-center international gastrointestinal (GI) endoscopy clinical trials using the Cellvizio(R) probe-based confocal laser endomicroscopy (pCLE) system. The "DONT BIOPCE study" and the "Cellvizio ERCP registry" were designed to evaluate if Cellvizio could improve diagnostic outcomes and biopsy efficiency in patients with Barrett's esophagus and those with suspected bile or pancreatic duct cancer, respectively. Both studies were initiated at the end of 2008 with groups of dedicated, world renowned clinical investigators from the United States of America (USA), France and Germany.
"This is a significant achievement and a fantastic clinical milestone for the company," said Sacha Loiseau, President, CEO and Founder of Mauna Kea Technologies. "We would like to thank all the physicians, study coordinators and staff involved in these clinical trials. We met the company's timeline in the set-up and execution of both studies, and are confident that the data generated will help us build the path for Cellvizio's wider adoption and routine use in GI endoscopy."
The "DONT BIOPCE" study (Detection of Neoplastic Tissue in Barrett's Esophagus with In vivO Probe-based Confocal Endomicroscopy) was a diagnostic, cross-over, double-blind randomized efficacy study focused on evaluating the diagnostic accuracy of Cellvizio for Barrett's esophagus surveillance. This study was led by principal investigator Prof. Prateek Sharma, M.D., from the Veterans Affairs Hospital in Kansas City, MO, and included four additional sites: two more in the USA, Mayo Clinic in Jacksonville, FL and Columbia-Presbyterian Hospital in New York, NY, as well as, Klinikum Rechts der Isar in Munich, Germany and University Hospital in Nantes, France. Over 100 patients were enrolled in the study. Follow up in this study continues and the study will be closed out by the end of 2009.
The "Cellvizio ERCP registry" was an observational prospective study in which data were collected from patients routinely undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) imaging and tissue sampling procedures for diagnosing pancreatic and bile duct cancers. A follow up phase of the trial is now underway. Six hospitals participated in this study: University of Colorado Hospital in Aurora, CO, with principal investigator Prof. Yang Chen, M.D.; Klinikum Rechts der Isar in Munich, Germany; Institut Paoli-Calmettes in Marseille, France; Beth Israel Deaconess in Boston, MA; University of Pittsburgh Medical Center in Pittsburgh, PA and Columbia-Presbyterian Hospital in New York, NY. A total of 130 patients were enrolled in the study. This study will be closed out once the follow-up is complete, which is anticipated to be no later than September 2010.
Preliminary data from both studies will be presented at the Gastro 2009 conference to be held in London from November 21-25, 2009. The principal investigator of each study will present interim results based on a subset of these data. Additional results from the studies are expected by the end of the year.
About Mauna Kea Technologies and Cellvizio
Mauna Kea Technologies believes that in continuously pushing the limits of observation of life and by helping physicians design new medical references and guidelines, it can improve patient care and reduce healthcare costs. Its flagship product, Cellvizio(R), is the world's smallest and most flexible microscope and the first system designed to provide live, real-time images of internal human tissues at the cellular level during endoscopic procedures. This new, advanced imaging technique helps physicians more effectively assess the tissues of interest and differentiate normal versus abnormal tissues that may be indicative of cancer, so patients potentially can be treated earlier and may undergo fewer biopsies. Physicians and thought leaders at more than 60 top medical institutions around the world have completed over 3,000 of these procedures an have published more than 25 peer-reviewed papers on the technology in leading medical journals. Cellvizio has premarket notification 510(k) clearance from the United States Food and Drug Administration and the European CE-Mark for use in the gastrointestinal and pulmonary tracts. For more information visit www.maunakeatech.com.