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11/03/2010 - Cellvizio brings hope in Alabama
Shyam Varadarajulu, from UAB explains in the Birmingham Medical News how Cellvizio improves diagnostics, patient care and helps reduce procedures cost and time.





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Clinical trials

In our ongoing efforts to improve patient care, Mauna Kea Technologies is working closely with exceptional practitioners at leading sites around the world to conduct clinical trials that will lead to new and improved diagnostic procedures with the Cellvizio® system. Since 2005, over 20 Cellvizio studies have been initiated in a wide range of applications in the GI tract and in the respiratory system, as well as other fields where confocal laser endomicroscopy may have an increasing impact. The following map depicts the locations of all ongoing company-sponsored Cellvizio clinical trials, including case series and feasibility studies, pilot trials and multicentric randomized controlled trials.

Please find below a short description of our ongoing clinical studies:

ERCP Registry : a registry of patients undergoing Cellvizio endomicroscopy and ERCP imaging procedures for diagnosing pancreatic and bile duct cancers (registered on clinicaltrials.gov, NCT00779688)

BE Multicentric Study USA + Europe : Detection Of Neoplastic Tissue in Barrett's esophagus with In vivO Probe-based Confocal Endomicroscopy (DONT BIOPCE) (registered on clinicaltrials.gov, NCT00795184)

Colonic Polyps : Probe-based confocal laser endomicroscopy for in-vivo differentiation of adenomas and non-neoplastic polyps

Ulcerative Colitis: Probe-based confocal laser endomicroscopy for in-vivo histological differentiation of neoplasia and non-neoplastic tissue in patients with Ulcerative Colitis

EUS-FNA pre-clinical feasibility trial : Feasibility of solid organs imaging during EUS-FNA procedures in pig models

Lung pilot trial : Probe-based confocal laser endomicroscopy for in vivo imaging of lung tissue in lung transplanted patients

And below is a description of soon-to-be completed clinical trials, as well as others sponsored by outside parties:

Reflux disease trial (sponsored by the Mayo Clinic) : Confocal laser microscopy in non erosive reflux disease (registered on clinicaltrials.gov, NCT00588939)

Urology pilot trial : Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology (registered on clinicaltrials.gov, NCT00801762)

Lung pilot trial (Rouen, France): Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases (ALVEOLE) (registered on clinicaltrials.gov, NCT00377338)

BE Multicentric Study Germany : Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study. (registered on clinicaltrials.gov,NCT00449995)



Sites currently working on Cellvizio studies sponsored by Mauna Kea Technologies:
Clinical sitesInvestigatorsStudies
Klinikum rechts der Isar, Munich, Germany A. Meining / M. Bajbouj ERCP Registry
DONT BIOPCE
EUSFNA
Paoli-Calmettes Institute, Marseille, France M. Giovannini ERCP Registry
AMC, Amsterdam, The Netherlands P. Fockens / E. Dekker Polyps study
UC study
EUSFNA
Mayo Clinic Jacksonville, USA M. Wallace / H. Wolfsen Polyps study
DONT BIOPCE
EUSFNA
Mayo Clinic Jacksonville, USA C. Keller Lung study
VA, Kansas City, USA P. Sharma / A. Bansal DONT BIOPCE
Columbia / NYP, New York, USA C. Lightdale / J.A. Abrams / P. Stevens ERCP Registry
DONT BIOPCE
BIDMC, Boston, USA R. Chuttani / D. Pleskow ERCP Registry
UCH, Denver, USA Y.K. Chen / R. Shah ERCP Registry
UPMC, Pittsburg, USA A. Slivka / J. Ahmad ERCP Registry
US Centers
European centers