Colon Cancer Clinical Trial
The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.
Carcinoma of the lower GI-tract is among the leading malignancies in the western world
causing a substantial morbidity, mortality and consequently a large burden to the health
care system in the diagnosis, treatment and follow-up of these patients.
The primary objectives of this study is to determine carcinoma- and adenoma lesion true
detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of
neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma-
and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare
carcinoma- and adenoma lesion true detection rates and the false detection rates of
fluorescence with standard colonoscopy and to characterize the safety profile of HAL
fluorescence colonoscopy.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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