Compare Fallopian Tube Cells Collected by MAKO 7 With Removed Ovarian/Tubal Tissue to Determine Presence of Malignant or Benign Cells



Status:Recruiting
Conditions:Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:August 20, 2018
End Date:December 31, 2019
Contact:Surbhi Sarna
Email:clin0507@nvisionmedical.com
Phone:408-655-3577

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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

Prospective, multi-center, non-randomized study to assess the ability of the MAKO 7 device to
collect cell samples from the fallopian tube that can be evaluated for the presence or
absence of malignancy.


Inclusion Criteria:

1. Subject is medically cleared for surgery

2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic
mass suspicious for malignancy

3. Subject must be 18 years of age

4. Subject must be able to provide informed consent

Exclusion Criteria:

1. Contraindication to hysteroscopy

2. Acute pelvic inflammatory disease

3. Active or recent lower pelvic infection

4. Pregnancy

5. Delivery or termination of a pregnancy in the past 6 weeks

6. Known tubal obstruction

7. Tubal ligation

8. Invasive carcinoma of the cervix or endometrium

9. Intolerance of anesthesia
We found this trial at
10
sites
800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Principal Investigator: Sarah H Kim, MD, MSCE
Phone: 215-829-7633
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Tri Dinh, MD
Phone: 904-953-8513
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ted L Anderson, MD, PhD
Phone: 615-343-9933
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Charles Landen, MD
Phone: 434-924-8660
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: David Miller, MD, FACOG, FACS
Phone: 214-648-7094
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Fort Worth, Texas 76104
Principal Investigator: Delbert A Johns, MD, PhD, FACOG, FACS
Phone: 817-922-2579
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Fort Worth, TX
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New York, New York 10032
Principal Investigator: Jason Wright, MD
Phone: 212-342-6895
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New York, NY
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Rochester, Minnesota 55905
Principal Investigator: Daniel Breitkopf, MD
Phone: 507-293-1487
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Rochester, MN
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San Francisco, California 94115
Principal Investigator: Bethan Powell, MD
Phone: 415-833-3480
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San Francisco, CA
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Seattle, Washington 98104
Principal Investigator: Charles W Drescher, MD
Phone: 206-215-2397
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Seattle, WA
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