A Powered Study to Evaluate the Sensitivity and Specificity of Cytological Evaluation of Fallopian Tube Samples Collected by the MAKO 7 in Determining the Presence of Malignancy

Brief description of study

You are being asked to take part in the nCYT research study. The purpose of this study is to evaluate how accurately cells that are collected from the fallopian tube can be categorized as benign or malignant. The MAKO 7 will be used to collect cell samples from the fallopian tube. You are being asked to participate in the study because you are a woman who is undergoing a surgery to remove your fallopian tubes and/or ovaries due to a suspicious pelvic mass. The MAKO 7 device has been cleared by the U.S. Food and Drug Administration (FDA) for collecting cell samples from the fallopian tubes. The purpose of this research study is to evaluate the ability to make positive or negative malignancy decisions using the cells collected from the fallopian tube by the MAKO 7 device.

Clinical Study Identifier: s18-00864
ClinicalTrials.gov Identifier: NCT03593681
Principal Investigator: Douglas Levine
Currently Recruiting

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