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

nVision Medical

Status: Completed

Conditions: Atypia Suspicious for Malignancy; BRCA2 Mutation; BRCA1 Mutation

Treatments: Device: MAKO 7

Study type: Observational

Funder types: Industry

Identifiers

NCT02974842

CLIN 0276

Details and patient eligibility

About

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

Full description

Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.

Enrollment: 50 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 a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
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 including tubal ligation
7. Invasive carcinoma of the cervix or endometrium
8. Intolerance of anesthesia

Trial design

50 participants in 1 patient group

Pre-Salpingo-Oophorectomy

Description:

Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.

Treatment:

Device: MAKO 7