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

nVision Medical50 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

BRCA1 Mutation BRCA2 Mutation Atypia Suspicious for Malignancy

Interventions

MAKO 7DEVICE

Hysteroscopic cell sampling

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Kaiser Permanente

San Francisco, California, United States

Kaiser Permanente

Walnut Creek, California, United States

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.

Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.

Time frame: Up to 60 days post-operatively

Data from ClinicalTrials.gov

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