A Minimally Invasive Device for Endometrial Imaging

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DESCRIPTION (provided by applicant): Abnormal uterine bleeding (AUB) is one of the most common reasons for a woman to visit her gynecologist, resulting in 3 million visits per year. We propose the development of a minimally invasive Endometrial Imaging Probe (EIP) to facilitate the evaluation of these patients. This device would enable creation of high- resolution visual maps of the endometrium. The procedure would involve a simple office-based procedure requiring about one minute, and not involve distention of the uterus as is required by hysteroscopy. During Phase I we developed a prototype probe with an outer diameter of 3.25mm, a novel omni-directional tip, and a servomotor. Specialized dewarping and collaging software combines several hundred image frames into a single high-resolution map of an axial segment of the endometrial cavity (from the fundus to the cervix). We successfully obtained proof-of-concept by imaging ex vivo human uteri. We now propose the development of advanced two-dimensional visual motion tracking. This will enable free-hand motion of the probe and allow it to be manipulated in a fashion similar to a uterine sound or an endometrial biopsy Pipelle. Most importantly, it will enable imaging of endometrium away from the primary axis of the fundus to the cervix. Thus, the cornua will be imaged and a visual map of the entire endometrial cavity will be produced. The system will then be tested in a pilot clinical study. Using a Semi-quantitative endometrial cavity evaluation system (SECES), we will determine the accuracy of EIP image relative to gross and histopathological evaluation of the endometrial cavity at the time of hysterectomy. It is our long term goal to produce a simple device to investigate patients with abnormal bleeding in the office setting.