CLIN 0507: The nCYT Study: 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
Evaluation of Fallopian Tube Cell Samples Collected by MAKO 7
Sponsor: nVision Medical Corporation
Enrolling: Female Patients Only
IRB Number: AAAR9484
U.S. Govt. ID: NCT03593681
Contact: Reena Vattakalam: 212-342-6895 /
Additional Study Information: 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 is designed to collect cells from the Fallopian tube. The MAKO 7 contains a very small balloon, which enters the Fallopian tube. Nothing rigid, such as metal, enters the Fallopian tube. The doctor will insert an instrument into the vagina, then into the uterus. Then the MAKO 7 will be inserted into the Fallopian tube. A second MAKO 7 device will be used on your other Fallopian tube. 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.
This study is closed
Jason Wright, MD
Do You Qualify?
Are you a female 18 years of age or older? Yes No
Will you undergo salpingo-oophorectomy (removal of fallopian tubes and ovary) or salpingectomy (removal of fallopian tubes)? Yes No
Have you had a prior tubal ligation (getting your tubes tied)? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Reena Vattakalam