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The WavSTAT Optical Biopsy System was approved by the FDA in November of2000 as safe and effective for adjunctive use during endoscopy of the colon toimprove the endoscopist's clinical sensitivity to identify pre-cancerouspolyps. The system received the CE Mark in Europe in September 2007. Theapproved WavSTAT System uses a low power, non-significant risk laser to scantissue and instantaneously help the physician determine whether small polypsare normal or pre-cancerous without physically removing the tissue. If theyare pre-cancerous, they are removed during the same procedure.
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Current standards of care dictate that if a patient has severe chronicsymptoms of heartburn, an endoscopy of the esophagus may be warranted and ifindicated, multiple physical biopsies are taken to check for pathology such asBarrett's esophagus, dysplasia or cancer. During endoscopic examination, thediseased tissue is not always visually apparent, especially at the pre-malignant stages. Therefore, the endoscopist physically biopsies visuallysuspicious areas within and outside the Barrett's area, areas with nodules orgenerally suspicious locations. The endoscopist also takes multiplerepresentative samples by physical biopsy in an effort to find diseasedtissue.
The clinical use of the WavSTAT System to improve the endoscopist'sclinical sensitivity in identifying dysplasia or cancer in the esophagus willbe evaluated. The hypothesis that the sensitivity of a WavSTAT-assistedendoscopic examination improves that of standard endoscopy alone will betested. If this hypothesis is proven, the physician should be able to takefewer physical biopsies, decrease the duration of the exam and minimize thediscomfort of the patient.
Background
Acid reflux, or heartburn, is a common ailment known to almost all adultsat some point in their lives. As many as 44% of adults in the United Statesreport having heartburn at least once a month; 14% report having it weekly and7% experience it daily. If heartburn occurs often, or other symptoms such asdifficulty swallowing, tissue damage or weight loss develop, a diagnosis ofgastro esophageal reflux disease (GERD) is considered. It is reported thatapproximately 50 million Americans have GERD symptoms. In most cases GERD isbenign, however, when GERD symptoms are frequent, i.e., twice per week, orchronic, i.e., five-plus years, a patient should be considered as a candidateto receive an endoscopy of the esophagus to check for a condition calledBarrett's esophagus.
Barrett's esophagus is a disease condition of the lower esophagus thoughtto be caused primarily by GERD. Approximately 10-20% of GERD patients arethought to have Barrett's esophagus. Barrett's is a condition in which thelining of the esophagus changes to a type of tissue similar to that normallyfound in the small intestine called intestinal metaplasia. Barrett's can onlybe confirmed by histologic examination of tissue biopsies obtained during anendoscopy of the esophagus.
Because the diagnosis of dysplasia has such a crucial impact on diseasemanagement and subsequent patient outcomes, a system that can aid theendoscopist in differentiating between suspect esophageal tissue withdysplasia or without dysplasia in real-time would have great clinical utility.
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