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

Area of Science:

• Gynecologic Endoscopy
• Medical Imaging Technology
• Reproductive Medicine

Background:

• Fallopian tube (FT) evaluation traditionally relies on invasive methods.
• Novel imaging techniques are needed for minimally invasive FT assessment.
• Multimodality imaging offers potential for enhanced diagnostic capabilities.

Purpose of the Study:

• To assess the feasibility and safety of a novel multimodality falloposcope.
• To evaluate the utility of multispectral fluorescence imaging (MFI) and optical coherence tomography (OCT) for FT imaging.
• To determine the safety profile of the device in a first-in-human study.

Main Methods:

• A novel falloposcope integrating MFI and OCT was used in 19 volunteers undergoing salpingectomy.
• The device was inserted hysteroscopically and advanced into the FTs.
• In vivo and ex vivo imaging were performed, followed by histological analysis for safety.

Main Results:

• The falloposcope was successfully inserted in 12 patients, with full cannulation to the distal segment in 4.
• MFI and OCT imaging were acquired in most cannulated FTs.
• No adverse events were reported; minor epithelial changes were noted histologically.

Conclusions:

• Falloposcopy with the novel multimodality endoscope is feasible and safe in humans.
• The technology shows promise for FT evaluation.
• Future iterations will focus on improving cannulation rates and image quality.