In vivo evaluation of a soft optical sensor for bleeding detection in colonoscopy.

Area of Science:

• Gastroenterology
• Medical Devices
• Surgical Technology

Background:

• Colonoscopy is vital for colorectal cancer screening but carries risks like undetected bleeding.
• A novel soft optical sensor add-on for colonoscopes aims to detect bleeding.
• Previous ex-vivo testing showed promise; this study reports in-vivo evaluation.

Purpose of the Study:

• To evaluate the in-vivo performance of a soft optical blood sensor for colonoscopy.
• To assess the sensor's accuracy, safety, and impact on clinical workflow.

Main Methods:

• The optical blood sensor was tested in two Yorkshire pigs by expert endoscopists.
• Evaluated parameters included bleeding detection accuracy, navigation time, workload (NASA TLX), safety, and durability.

Main Results:

• The sensor achieved 92% accuracy, 83% precision, 100% sensitivity, and 87% specificity.
• No significant clinical workflow interruption or increased workload was observed.
• The sensor remained intact, and no colon damage occurred during trials.

Conclusions:

• The soft optical blood sensor reliably detects bleeding in pre-clinical in-vivo trials.
• The device shows potential for clinical translation without workflow disruption.
• Further evaluation with more users is recommended for clinical progression.