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

Boston Scientific

Status: Completed

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

Treatments: Device: Hysteroscopic cell sampling of the fallopian tube

Study type: Observational

Funder types: Industry

Identifiers

NCT03593681

CLIN 0507

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design