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

Area of Science:

• Gynecological oncology
• Medical imaging
• Biomedical engineering

Background:

• High-grade serous ovarian cancer, the deadliest gynecological cancer, often originates in the fallopian tubes (FTs).
• Early detection significantly improves survival rates, but current methods are limited.
• Autofluorescence imaging, multispectral fluorescence imaging (MFI), and optical coherence tomography (OCT) show promise for detecting precancerous and cancerous lesions in FTs and ovaries.

Purpose of the Study:

• To develop and evaluate a novel falloscope for in vivo imaging of the fallopian tubes (FTs) using MFI and OCT.
• To assess the safety and feasibility of FT imaging prior to salpingectomy in a pilot study.
• To describe iterative improvements made to the falloscope based on clinical feedback.

Main Methods:

• Development of a clinical prototype falloscope with a $$ diameter.
• Minimally invasive introduction via a hysteroscope and catheter.
• Acquisition of navigation video, MFI, and OCT images of human FTs in 12 volunteers.

Main Results:

• The falloscope successfully acquired in vivo images of the fallopian tubes.
• Iterative improvements enhanced device robustness, usability, and image quality.
• Feedback from stakeholders guided modifications to the imaging system and accessories.

Conclusions:

• The falloposcope is a feasible tool for in vivo imaging of the fallopian tubes.
• Iterative prototyping has significantly improved the device's robustness and functionality.
• Further trials are warranted to establish the falloscope's role in early ovarian cancer detection.