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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-02

Study Completion Date

2017-09-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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BRCA1 Mutation BRCA2 Mutation Atypia Suspicious for Malignancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Salpingo-Oophorectomy

Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.

MAKO 7

Intervention Type DEVICE

Hysteroscopic cell sampling

Interventions

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MAKO 7

Hysteroscopic cell sampling

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No