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New Clinical Studies Confirm Mauna Kea Technologies' Cellvizio(R) GI in Range of Procedures
Date:10/30/2007

eria for use of Cellvizio(R) GI in diagnosing GI-GVHD.

Promising results were reported in a study evaluating Cellvizio(R) GI in the differential diagnosis of indeterminate biliary strictures (Abstract PS-W- 24). Standard approaches to making this differential diagnosis have certain limitations, which may be overcome by Cellvizio(R) GI. In 7 patients, the Cellvizio(R) probe was introduced directly into the common bile duct. In a further 7 patients, the further miniaturized probe was introduced and placed to suspected lesions under visual control via a cholangioscope. The probe could be introduced in all patients, and imaging of the cellular structures of the bile duct epithelium was possible in all cases. In two patients in whom the probe was inserted directly, the probe could not be inserted far enough to reach the stenosis and corresponding histology samples were unable to be obtained in these cases. No side effects were observed. Cellvizio(R) GI revealed normal findings in benign cases. Biliary cancers showed features of thickened vessels with black cells in 5 of 6 cases of malignancy. Investigators conclude that Cellvizio(R) GI enables imaging of cellular details even in small ducts such as in the biliary system. The system has the potential to increase the diagnostic accuracy for further differentiation of strictures and stenosis, which is one of the most poorly diagnosed GI conditions and can lead to cancers with the poorest prognosis: cholangiocarcinoma or pancreatic cancer.

Another study evaluated the ability of Cellvizio(R) GI to evaluate pathologic features of small intestinal pathology (Abstract PS-M-08). The study examined 20 patients with known celiac sprue and well controlled disease. Biopsies were taken from areas evaluated with Cellvizio(R) GI to allow precise comparison with histology findings. A total of 80 GI sites were evaluated. Seven patients had pathological findings consistent with celiac disease, two of which were classified as Ma
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