While there are a plethora of in-vivo spectroscopic techniques that have demonstrated the ability to detect a number of diseases in research trials, very few techniques have successfully become a fully realized clinical technology. This is primarily due to the stringent demands on a clinical device for widespread implementation. Some of these demands include: simple operation requiring minimal or no training, safe for in-vivo patient use, no disruption to normal clinic workflow, tracking of system performance, warning for measurement abnormality, and meeting all FDA guidelines for medical use. Previously, our group developed a fiber optic probe-based optical sensing technique known as low-coherence enhanced backscattering spectroscopy (LEBS) to quantify tissue ultrastructure in-vivo. Now we have developed this technique for the application of prescreening patients for colonoscopy in a primary care (PC) clinical setting. To meet the stringent requirements for a viable medical device used in a PC clinical setting, we developed several novel components including an automated calibration tool, optical contact sensor for signal acquisition, and a contamination sensor to identify measurements which have been affected by debris. The end result is a state-of-the-art medical device that can be realistically used by a PC physician to assess a person’s risk for harboring colorectal precancerous lesions. The pilot study of this system shows great promise with excellent stability and accuracy in identifying high-risk patients. While this system has been designed and optimized for our specific application, the system and design concepts are universal to most in-vivo fiber optic based spectroscopic techniques.
Adam Eshein, The-Quyen Nguyen, Andrew J. Radosevich, Bradley Gould, Wenli Wu, Vani Konda, Leslie W. Yang, Ann Koons, Seth Feder, Vesta Valuckaite, Hemant K. Roy, and Vadim Backman, "Creating an optical spectroscopy system for use in a primary care clinical setting
(Conference Presentation)," Proc. SPIE 9698, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XIV, 96980V (Presented at SPIE BiOS: February 16, 2016; Published: 3 May 2016); https://doi.org/10.1117/12.2211421.4828055417001.
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