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

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

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

Study Overview

• Status: Completed
• Conditions: BRCA1 Mutation; BRCA2 Mutation; Atypia Suspicious for Malignancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Kaiser Permanente
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put them at high risk of developing malignancy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.	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.	Up to 60 days post-operatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2016
• Primary Completion (ACTUAL): September 27, 2017
• Study Completion (ACTUAL): September 27, 2017

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (ESTIMATE): November 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CLIN 0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO