de Leon Maria C B, Wu Howard H, Lennon Ashley E, Del Priore Giuseppe
J Reprod Med. 2016 May-Jun;61(5-6):243-8.
To evaluate a new device for obtaining endometrial biopsies which combines global endometrial disruption using a brush with a built-in suction process.
Endometrial biopsies were collected, using the GDP-Tao device, from fresh uteri hysterectomy specimens after completion of surgery. Results were compared to final hysterectomy pathology. Specificity and sensitivity and positive and negative predictive values were calculated.
Based on a sample size calculation, 42 patients were included in this study. Endometrial tissue adequate for diagnosis was obtained in 93% (39/42) of biopsies. Classifying atypia as a positive result, the sensitivity of the new device was 96% (23/24), with specificity of 87% (13/15). The positive predictive value was 92% (23/25) and the negative predictive value, 93% (13/14). There were 2 nondiagnostic (ND) samples from GDP-Tao with final pathology of benign endometrium. One specimen was ND on both GDP-Tao and final pathology due to absence of tissue after prior endometrial ablation. When stratified by uterine size, benign or malignant, the results were similar.
Our validation study showed encouraging results for the GDP-Tao, which combines tissue disruption and aspiration into a single process. The device provides a reliable means of obtaining adequate samples to accurately detect endometrial cancer with a high negative and positive predictive value.
