Trial Outcomes & Findings for Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance (NCT NCT02974842)

Last Updated: 2020-04-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Up to 60 days post-operatively

Results posted on

2020-04-21

Participant Flow

Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation were recruited from three gynecologic oncology centers in the United States.

This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.

Participant milestones

Participant milestones
Measure	MAKO 7 Group Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation.
Overall Study STARTED	50
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	MAKO 7 Group Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation.
Overall Study Withdrawal by Subject	4
Overall Study Screen failures	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eligible Participants With Hysteroscopic Attempt n=42 Participants Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria.
Age, Continuous	56.6 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	29 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American or other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic or non-Latino	3 Participants n=5 Participants
Region of Enrollment United States	42 Participants n=5 Participants
Reason for Surgery Pelvic mass suspicious for malignancy	34 Participants n=5 Participants
Reason for Surgery BRCA 1 or BRCA 2 mutations	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 days post-operatively

Population: Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results.

Outcome measures

Outcome measures
Measure	MAKO 7 Group n=44 fallopian tubes Fallopian tubes with adequate cytology samples obtained with MAKO 7 with available surgical histology results.
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. Concordant	42 fallopian tubes
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. Discordant	2 fallopian tubes

Adverse Events

MAKO 7 Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MAKO 7 Group n=42 participants at risk Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria.
Reproductive system and breast disorders Uterine perforation	7.1% 3/42 • Number of events 3 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
General disorders Nausea	16.7% 7/42 • Number of events 8 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
Surgical and medical procedures Pain	52.4% 22/42 • Number of events 24 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
General disorders Dizziness	9.5% 4/42 • Number of events 4 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
General disorders Fatigue	16.7% 7/42 • Number of events 7 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
General disorders Hypotension	14.3% 6/42 • Number of events 7 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
Blood and lymphatic system disorders Anemia	26.2% 11/42 • Number of events 11 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
Blood and lymphatic system disorders Hematological Dyscrasia	16.7% 7/42 • Number of events 10 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
General disorders Electrolyte Imbalance	16.7% 7/42 • Number of events 9 • Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.

Additional Information

Surbhi Sarna

nVision Medical

Phone: 408 655 3577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place