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.
Additional Information
© The Author(s) 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Received 09 January 2020; Accepted 21 January 2021; Published 11 February 2021. This work was funded in part through the California Institute of Technology-City of Hope Biomedical Initiative Award. We thank Dr. Andrew Blakely for his careful review of the manuscript. Author Contributions: L.L., M.W., C.H.Y., and J.L. conceived the study design. L.L., M.W., C.H., H.J., H.L. and J.L. completed the data acquisition. All authors were involved in the data analysis and interpretation. L.L., M.I., and M.W. drafted the manuscript. All authors assisted in the critical review and revision of the manuscript. Final approval of the manuscript was given by all authors. Competing interests: The imaging device reported in this manuscript has been patented by C. Han, H. Jiangtao, L. Lai, and C.H. Yang. U.S. Patent Application No. 14/580,074. The patent was issued a Notice of Allowance on September 13, 2019. The remaining co-authors have no conflict of interest with the content of this article.Attached Files
Published - s41598-021-82962-2.pdf
Files
| Name | Size | Download all |
|---|---|---|
|
md5:b748dc6728c91ad0d5a07b6996bbdb08
|
1.3 MB | Preview Download |
Additional details
- PMCID
- PMC7878729
- Eprint ID
- 108080
- Resolver ID
- CaltechAUTHORS:20210217-070548457
- Caltech-City of Hope Biomedical Initiative
- Created
-
2021-02-18Created from EPrint's datestamp field
- Updated
-
2021-11-16Created from EPrint's last_modified field