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The miniaturization of optical endoscopes has enabled high-resolution imaging in small caliber, difficult to access organs. We developed a sub-mm triple-modality microendoscopy system, the falloposcope, to access and enable earlier detection of ovarian cancer in the fallopian tubes. We assessed the feasibility of clinical translation, iterative modifications to the design and interventional approach, and the role of the interventional radiologist in future implementation. The flexible 0.8 mm diameter falloposcope enables navigation guidance and identification of surface-level precancerous areas with front-facing reflectance and multispectral fluorescence imaging (MFI), respectively, and includes a side-firing optical coherence tomography (OCT) probe for surveillance of tubal wall morphology up to 3 mm in depth. The axial and lateral resolution of the OCT system are 10.7 μm and ≤17 μm, respectively. With institutional review board approval, tubal catheterization and imaging was performed in 19 volunteers prior to standard of care salpingectomy. The tubal ostia were identified under hysteroscopic guidance and standard interventional equipment and techniques were employed to cannulate the tubes prior to falloposcope insertion. Patient demographic and health history information was collected. Explanted tissue samples were collected and imaged for ex-vivo comparison to in-vivo imaging and ground-truth histology. The mean age of the cohort was 48.3 ± 12.3 years (n=18). Falloposcope catheterization was attempted in 14/19 patients (73.6%) and was not attempted in cases of proximal tubal obstruction or other clinical or technical challenges. The furthest distance reached was the uterine cornu (2/14, 14.3%), proximal (7/14, 50%), middle (1/14, 7.1%), and distal (4/14, 28.6%) tube. In-vivo images were successfully acquired using OCT (12/14, 85.7%), MFI (5/14, 35.7%), and reflectance (11/14, 78.6%). Histologic analysis of samples from 9 patients showed a mean proximal luminal diameter of 0.676 ± 0.599 mm and few areas with non-significant epithelial denudation. There were no adverse events. Clinical translation of a novel sub-mm triple-modality falloposcope was successful and shows promise as an adjunct to selective salpingography and tubal catheterization procedures. Collaborative efforts between engineers, gynecologists, and interventional radiologists will facilitate future design modifications, methods of use, diagnostic assessment, and expanded clinical utility.
Long et al. (Wed,) studied this question.