N/A
N=50
Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
BRCA1 Mutation · BRCA2 Mutation · Atypia Suspicious for Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT02974842 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. — 42; 2 fallopian tubes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MAKO 7 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- nVision Medical
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. |
42; 2 | — |
Summary
This study evaluates the ability of the MAKO 7 device to collect various cells
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
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.