N/A Completed N=50

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

BRCA1 Mutation · BRCA2 Mutation · Atypia Suspicious for Malignancy

Source: ClinicalTrials.gov NCT02974842 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcomePrimary: Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. — 42; 2 fallopian tubes

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.	42; 2	—

Eligibility Criteria

Inclusion Criteria

Subject is medically cleared for surgery
Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
Subject must be 18 years of age
Subject must be able to provide informed consent

Exclusion Criteria

Contraindication to hysteroscopy
Acute pelvic inflammatory disease
Active or recent lower pelvic infection
Pregnancy
Delivery or termination of a pregnancy in the past 6 weeks
Known tubal obstruction including tubal ligation
Invasive carcinoma of the cervix or endometrium
Intolerance of anesthesia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02974842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.