Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy

Completed

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms, Ovary Cancer, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, High Grade Serous Carcinoma, Peritoneal Carcinoma, Peritoneal Neoplasms, Adnexal Mass, Ovarian Diseases

In brief

Prospective, multi-center, non-randomized study to assess the ability of the Cytuity device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.

Key facts

Study ID

NCT03593681

Run by

Boston Scientific Corporation

People needed

150

Starts

2018-08-27

Expected to finish

2020-02-14

Last updated by the study team

2021-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is medically cleared for surgery
• Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
• Subject must be 18 years of age
• Subject must be able to provide informed consent

You may not qualify if…

• Contraindication to hysteroscopy
• Acute pelvic inflammatory disease
• Active or recent lower pelvic infection
• Pregnancy
• Delivery or termination of a pregnancy in the past 6 weeks
• Known tubal obstruction
• Tubal ligation
• Invasive carcinoma of the cervix or endometrium
• Intolerance of anesthesia

Where it is running

• Scripps Clinic Medical Group — San Diego, California, United States
• Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York Presbyterian Hospital — New York, New York, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Scott & White Research Institute — Fort Worth, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Swedish Health Services — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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