Iterative prototyping based on lessons learned from the falloposcope in vivo pilot study experience

Abstract

High grade serous ovarian cancer is the most deadly gynecological cancer, and it is now believed that most originate in the fallopian tubes (FTs). We developed a FT endoscope, the falloposcope, as a method for detecting ovarian cancer. The falloposcope clinical prototype is being implemented in a pilot study with 20 volunteers (12 enrolled to date) to evaluate the safety and feasibility of FT imaging prior to standard of care salpingectomy in normal-risk volunteers. The falloposcope is approximately 0.8 mm in diameter and is introduced via a minimally invasive approach through a commercially available hysteroscope and introducing catheter. To date, FT navigation video, multispectral reflectance and fluorescence images, and optical coherence tomography (OCT) of human FT have successfully been acquired. This manuscript describes the fabrication improvements and iterative design changes that have been introduced to improve usability and reduce failure points based on clinical implementation. We discuss falloposcope improvements made with respect to the following subjects: improving perceived image quality with the fiber bundle, GRIN lens stray light, and improving the proximal imaging system. Navigation and MFI are limited by the 3,000 element fiber bundle and lens working distance (WD). A future system is being developed with a 10,000 element fiber bundle, more uniform illumination, a closer WD lens, and wire cytology instead of OCT probe.