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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-27

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Hysteroscopic cell sampling of the fallopian tube

Hysteroscopic fallopian tube biopsy

Intervention Type DEVICE

Other Intervention Names

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Cytuity

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No