Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance

Completed

Conditions studied: BRCA1 Mutation, BRCA2 Mutation, Atypia Suspicious for Malignancy

In brief

This study evaluates the ability of the MAKO 7 device to collect various cells

Key facts

Study ID

NCT02974842

Run by

nVision Medical

People needed

50

Starts

2016-11-02

Expected to finish

2017-09-27

Last updated by the study team

2020-04-21

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 a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
• 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 including tubal ligation
• Invasive carcinoma of the cervix or endometrium
• Intolerance of anesthesia

Where it is running

• Kaiser Permanente — San Francisco, California, United States
• Kaiser Permanente — Walnut Creek, California, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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