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

• Sponsor: nVision Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02974842
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Actual Duration (Months): 10.8
• Patients Per Site: 16.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
BRCA1 Mutation; BRCA2 Mutation; Atypia Suspicious for Malignancy	Device: MAKO 7

Detailed Description

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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cytological Evaluation of Specimens Collected With the MAKO 7 Device in Pre Salpingo-Oophorectomy Subjects for Determination and/or Differentiation of Normal Versus Atypical Versus Malignant Cells
• Actual Study Start Date: Nov 2, 2016
• Actual Primary Completion Date: Sep 27, 2017
• Actual Study Completion Date: Sep 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Pre-Salpingo-Oophorectomy Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.	Device: MAKO 7; Hysteroscopic cell sampling

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente	San Francisco	California	United States	94115
2	Kaiser Permanente	Walnut Creek	California	United States	94596
3	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• nVision Medical

Investigators

• Study Director: Surbhi Sarna, B.S., nVision Medical Corp

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2017

More Information

Publications

None provided.

• Responsible Party: nVision Medical
• ClinicalTrials.gov Identifier: NCT02974842
• Other Study ID Numbers: CLIN 0276
• First Posted: Nov 29, 2016
• Last Update Posted: Apr 21, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neoplasms

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.

Arm/Group Title	MAKO 7 Group
Arm/Group Description	Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation.
Period Title: Overall Study
STARTED	50
COMPLETED	42
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Eligible Participants With Hysteroscopic Attempt
Arm/Group Description	Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria.
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.6 (15.7)
Sex: Female, Male (Count of Participants)
Female	42 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	6 14.3%
Caucasian	29 69%
Hispanic or Latino	3 7.1%
Native American or other Pacific Islander	1 2.4%
Non-Hispanic or non-Latino	3 7.1%
Region of Enrollment (Count of Participants)
United States	42 100%
Reason for Surgery (Count of Participants)
Pelvic mass suspicious for malignancy	34 81%
BRCA 1 or BRCA 2 mutations	8 19%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MAKO 7 Group
Arm/Group Description	Fallopian tubes with adequate cytology samples obtained with MAKO 7 with available surgical histology results.
Measure Participants	29
Measure fallopian tubes	44
Concordant	42
Discordant	2

Adverse Events

Time Frame	Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
Arm/Group Title	MAKO 7 Group
Arm/Group Description	Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria.
All Cause Mortality
	MAKO 7 Group
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Serious Adverse Events
	MAKO 7 Group
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Other (Not Including Serious) Adverse Events
	MAKO 7 Group
	Affected / at Risk (%)	# Events
Total	25/42 (59.5%)
Blood and lymphatic system disorders
Anemia	11/42 (26.2%)	11
Hematological Dyscrasia	7/42 (16.7%)	10
General disorders
Nausea	7/42 (16.7%)	8
Dizziness	4/42 (9.5%)	4
Fatigue	7/42 (16.7%)	7
Hypotension	6/42 (14.3%)	7
Electrolyte Imbalance	7/42 (16.7%)	9
Reproductive system and breast disorders
Uterine perforation	3/42 (7.1%)	3
Surgical and medical procedures
Pain	22/42 (52.4%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.