Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging

Abstract

Global anal cancer incidence is increasing. High resolution anoscopy (HRA) currently screens for anal cancer, although the definitive test remains unknown. To improve on intraluminal imaging of the anal canal, we conducted a first-in-human study to determine feasibility and safety of a high-resolution, wide field-of-view scanning endoscope. Fourteen patients, under an IRB-approved clinical study, underwent exam under anesthesia, HRA, and imaging with the experimental device. HRA findings were photographed using an in-line camera attached to the colposcope and compared with the scanning endoscope images. Patients were followed up within 2 weeks of the procedure. The imaging device is inserted into the anal canal and the intraluminal surface is digitally photographed in 10 s and uploaded to a computer monitor for review. Ten patients completed imaging with the device. Three patients were not imaged due to severe anal stenosis. One patient was not imaged due to technical device malfunction. The device images were compared to the HRA images. No adverse event attributable to the device was reported. The intraluminal scanning endoscope can be used for circumferential anal canal imaging and is safe for clinical use. Future clinical studies are needed to evaluate the performance of this device.

Flexible Over-the-Tube Device for Soft-Tethered Colonoscopy

“…Consistent with the current early developmental stage, we addressed a flexible demonstrator with an OD of around 26 mm (representing an average lower anatomical limit [23]) and a length not exceeding 100 mm [24], capable of operating with a soft tether having a diameter up to approximately 10 mm [12]. The targeted size is similar to that of current conventional anoscopes (featuring diameter and length in the range of 15-30 and 65-90 mm, respectively [25], [26], [27]. Moreover, based on previous investigations by the research group [28], we assumed that FOD had to overcome a resistive force F r = 2N.…”