e16522 Background: Currently there is no consensus on the best device and technique for obtaining endometrial biopsies to rule out cancer. Outpatient methods available include aspiration devices (Pipelle) and disruption devices (Tao brush). This study evaluated a new device which combines Global endometrial Disruption using a brush with a built in suction Process (GDP-Tao). Methods: After IRB approval, endometrial specimens were collected using the GDP-Tao from fresh uteri after completion of hysterectomies. Endometrial pathology results from the new device were compared to the final hysterectomy diagnosis by blinded review. Results: Patients (n = 33) were 29-86 years old (median 56), 67% obese, 52% menopausal. Uterine sounds were 2.5-11cm (median 6.6 cm), weight 45-3500g (median 238g), 15% of cervical os were stenotic but all allowed the device to pass without other instrumentation with overall diagnostic rate of 91% (30/33) 15/15 pathologically confirmed malignant specimens were correctly identified by the new device including 2 GDP-Tao specimens with atypical hyperplasia (AH) and hysterectomy pathology with AH and focal adenocarcinoma. Classifying any atypia from the GDP-Tao as “positive” then the detection rate for malignancy was 100% (PPV). 11/11 samples were benign in GDP-Tao and final pathology. There were 3 non-diagnostic (ND) samples from GDP-Tao with final pathology of benign endometrium. One specimen was ND due to absence of tissue from prior endometrial ablation. There was one device result of “proliferative endometrium” with final pathology of focal complex atypical hyperplasia and one device result of “rare atypical cells” with final diagnosis of endometrial polyp. Sensitivity and specificity were 94% and 92%, and negative predictive value was 82% for the identification of both atypical hyperplasia and malignancy. When stratified by uterine size, benign or malignant, the results were similar. Conclusions: Our validation study showed encouraging data thatthis new endometrial sampling device, which combines tissue disruption and aspiration into a single process, provides a reliable mean of obtaining adequate sample to accurately detect endometrial cancer with a high negative and positive predictive value.
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