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

NCT03593681CompletedOBSERVATIONAL

Summary

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

Lead Sponsor

Boston Scientific Corporation

Enrollment

150

Start Date

2018-08-27

Completion Date

2020-02-14

Study Type

OBSERVATIONAL

Official Title

The nCYT Study: A Powered Study to Evaluate the Sensitivity and Specificity of Cytological Evaluation of Fallopian Tube Samples Collected by the Cytuity in Determining the Presence of Malignancy

Interventions

Hysteroscopic cell sampling of the fallopian tube

Conditions

Fallopian Tube CancerOvarian CancerOvarian NeoplasmsOvary CancerFallopian Tube NeoplasmsFallopian Tube AdenocarcinomaHigh Grade Serous CarcinomaPeritoneal CarcinomaPeritoneal NeoplasmsAdnexal MassOvarian Diseases

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement

Evaluate the sensitivity and specificity of the cytological samples collected from the fallopian tube in determining the presence or absence of malignancy for fallopian tube involvement as compared to the surgical histology results. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.