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Completed

NCT Number: NCT02974842

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

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

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Key information

Conditions

BRCA1 Mutation Atypia Suspicious for Malignancy BRCA2 Mutation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kaiser Permanente, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is medically cleared for surgery
  • Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
  • Subject must be 18 years of age
  • Subject must be able to provide informed consent

Exclusion criteria

  • Contraindication to hysteroscopy
  • Acute pelvic inflammatory disease
  • Active or recent lower pelvic infection
  • Pregnancy
  • Delivery or termination of a pregnancy in the past 6 weeks
  • Known tubal obstruction including tubal ligation
  • Invasive carcinoma of the cervix or endometrium
  • Intolerance of anesthesia

Treatment and study plan

MAKO 7

Device

Hysteroscopic cell sampling

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

nVision Medical

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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