A MINIMALLY INVASIVE DEVICE FOR ENDOMETRIAL IMAGING

DESCRIPTION (provided by applicant):Endometrial carcinoma is the most common gynecological cancer in the United States, affecting over 1 in 50 women during her lifetime. Image-guided biopsy using the hysteroscope is significantly more sensitive than blind endometrial biopsy (EMB) for diagnosis of endometrial pathology. However, the majority of gynecologists do not use hysteroscopy, largely due to a steep learning curve. Therefore, we propose development of an automated minimally invasive imaging device which is as easy to use as an EMB. The device uses a 3mm rigid rod-optic endoscope. It is automatically controlled by a servomotor to produce a single two-dimensional image of the entire endometrial cavity, including visualization of lesions. Subsequently, a directed biopsy may be accomplished using the servomotor system and the coordinates of the lesion from the Endometrial Map. The Phase I prototype will incorporate a 360-degree panoramic imaging endoscope, special image-processing software, and full color CCD technology to produce a single integrated Endometrial Map. We will test this system in ex-vivo human uteri and characterize its performance relative to visual inspection of the dissected uterus. If we obtain proof-of-concept of the imaging system, we hope to proceed to Phase II, which will focus on integration of the biopsy apparatus, and testing the device in an animal model and in a clinical study. It is our long-term goal that the device will be used as a minimally invasive tool for accurate identification and directed biopsy of endometrial pathology. PROPOSED COMMERCIAL APPLICATION: This year alone there will be 38,300 new cases of endometrial cancer in women. If the device proves to create a simple method to image the endometrium and direct biopsies, it will have a major impact on the clinical practice of gynecology.