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

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ClinicalTrials.gov Identifier: NCT02974842
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
nVision Medical

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

Condition or disease Intervention/treatment
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 Type : Observational
Estimated 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 : November 2, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

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




Primary Outcome Measures :
  1. Concordance between cytology and pathology results [ Time Frame: Up to 60 days post-operatively ]

Biospecimen Retention:   Samples Without DNA
Cell samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974842


Locations
United States, California
Kaiser Permanente
San Francisco, California, United States, 94115
Sponsors and Collaborators
nVision Medical

Responsible Party: nVision Medical
ClinicalTrials.gov Identifier: NCT02974842     History of Changes
Other Study ID Numbers: CLIN 0276
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No