NCT02974842

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

Completed Results posted Last updated 21 April 2020

What this trial tests

trial testing MAKO 7 in BRCA1 Mutation in 50 participants. Completed in 27 September 2017.

Timeline

2 November 2016

Primary endpoint
27 September 2017

27 September 2017

Quick facts

Lead sponsor	nVision Medical
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	2 November 2016
Primary completion	27 September 2017
Estimated completion	27 September 2017
Sites	3 locations across United States

Drugs / interventions tested

• MAKO 7

Conditions studied

• BRCA1 Mutation — all drugs for BRCA1 Mutation →
• BRCA2 Mutation — all drugs for BRCA2 Mutation →
• Atypia Suspicious for Malignancy — all drugs for Atypia Suspicious for Malignancy →

Sponsor

nVision Medical

Who can join

18 and older, female only, with BRCA1 Mutation or BRCA2 Mutation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. Primary · Up to 60 days post-operatively

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.

Group	Value	95% CI
MAKO 7 Group	42
MAKO 7 Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MAKO 7 Group

Serious: 0/42 (0%)

Deaths: 0/42

Other adverse events (9 terms — click to expand)

Reaction	System	MAKO 7 Group
Pain	Surgical and medical procedures	—
Anemia	Blood and lymphatic system disorders	—
Nausea	General disorders	—
Fatigue	General disorders	—
Hematological Dyscrasia	Blood and lymphatic system disorders	—
Electrolyte Imbalance	General disorders	—
Hypotension	General disorders	—
Dizziness	General disorders	—
Uterine perforation	Reproductive system and breast disorders	—

Data from ClinicalTrials.gov NCT02974842 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cytologic studies of <i>in vivo</i> fallopian tube specimens in patients undergoing salpingo-oophorectomy.
   Pramanik S, Yang E, Wu W. · · 2020 · cited 1× · PMID 33093855 · DOI 10.25259/cytojournal_7_2020