Optical biopsy system enters final phase of clinical study to determine esophageal cancer diagnosis capability
SEPTEMBER 19, 2008 -- SpectraScience, Inc. (San Diego, CA), has shipped its WavSTAT Optical Biopsy System to both the Mayo Clinic and the University of California San Diego/VA to complete the final phase of a three-year study. The clinics will test the optical biopsy system as an adjunctive clinical tool to identify dysplasia or cancer in the esophagus. WavSTAT promises to reduce biopsies, decrease exam duration, and minimize patient discomfort; it is currently FDA approved for colonscopy.
SEPTEMBER 19, 2008 -- SpectraScience, Inc. (San Diego, CA), has shipped its WavSTAT Optical Biopsy System to both the Mayo Clinic (Rochester, MN) and the University of California San Diego/VA (La Jolla, CA) to complete a study at each site. The purpose of the study is to demonstrate the clinical value of the optical biopsy system as an adjunctive tool to improve an endoscopists' clinical sensitivity in identifying dysplasia or cancer in the esophagus. This will be the final phase of the study which has been conducted over the past three years.
The WavSTAT Optical Biopsy System was approved by the FDA in November of 2000 as safe and effective for adjunctive use during endoscopy of the colon to improve the endoscopist's clinical sensitivity to identify pre-cancerous polyps. The system received the CE Mark in Europe in September 2007. WavSTAT uses a low power laser to scan tissue and instantaneously help the physician determine whether small polyps are normal or pre-cancerous without physically removing the tissue. If they are pre-cancerous, they are removed during the same procedure.
The study will evaluate clinical use of the WavSTAT System to improve the endoscopist's clinical sensitivity in identifying dysplasia or cancer in the esophagus. And, it will test the hypothesis that the sensitivity of a WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone. If this hypothesis is proven, the physician should be able to take fewer physical biopsies, decrease the duration of the exam and minimize the discomfort of the patient.
Current standards of care dictate that if a patient has severe chronic symptoms of heartburn, an endoscopy of the esophagus may be warranted and if indicated, multiple physical biopsies are taken to check for pathology such as Barrett's esophagus, dysplasia or cancer. During endoscopic examination, the diseased tissue is not always visually apparent, especially at the pre- malignant stages. Therefore, the endoscopist physically biopsies visually suspicious areas within and outside the Barrett's area, areas with nodules or generally suspicious locations. The endoscopist also takes multiple representative samples by physical biopsy in an effort to find diseased tissue.
SpectraScience WavSTAT Optical Biopsy System