First Clinical Feasibility and Safety Study of a Novel Multimodality Fallopian Tube Imaging Endoscope.

Abstract

Study objective: We present the results of the first feasibility and safety study of a novel multi-modality falloposcope, in 19 volunteers. The falloposcope incorporated multispectral fluorescence imaging (MFI) and optical coherence tomography (OCT) for evaluation of the fallopian tubes (FT).

Methods: Nineteen females undergoing elective salpingectomy were recruited in this IRB-approved study. During a 15-min pause in standard of care surgery, a novel falloposcope was inserted under hysteroscopic guidance and advanced into the FTs. The furthest cannulated segment (proximal, middle, distal) was noted, and acquisition of MFI and OCT images was attempted at each segment in a retrograde fashion. Surgical discard samples from each segment of both FTs were obtained per pathology discretion for ex vivo imaging. All samples were processed for histology to evaluate any device-related injury.

Results: The falloposcope was inserted into the FTs of 12 patients and successfully cannulated the entire length of the tube to the distal segment in one-third (4/12) of attempts. OCT and/or MFI images were obtained of all but one cannulated FT. Cannulation failure was attributed to proximal anatomy or obstruction, tortuosity of the FT, and limited study time. There were no adverse events related to the falloposcopy procedure. Focal epithelial cell denudation in the proximal segments of three patients, without no stromal involvement, was observed by histological examination. OCT images acquired in vivo showed characteristic tissue microstructures but were more susceptible to artifacts compared to ex vivo images.

Conclusions: The results of this first-in-human study suggest that falloposcopy with a novel multimodality imaging endoscope is feasible and safe. Future procedural and design modifications will be implemented to improve image quality and cannulation success rates.