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Compare Fallopian Tube Cells Collected by MAKO 7 With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy (nCYT)

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ClinicalTrials.gov Identifier: NCT03593681
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
nVision Medical

Brief Summary:
Prospective, multi-center, non-randomized study to assess the ability of the MAKO 7 device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.

Condition or disease Intervention/treatment
Fallopian Tube Cancer Ovarian Cancer Ovarian Neoplasms Ovary Cancer Fallopian Tube Neoplasms Fallopian Tube Adenocarcinoma High Grade Serous Carcinoma Peritoneal Carcinoma Peritoneal Neoplasms Adnexal Mass Ovarian Diseases Device: Hysteroscopic cell sampling of the fallopian tube

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The nCYT Study: A Powered Study to Evaluate the Sensitivity and Specificity of Cytological Evaluation of Fallopian Tube Samples Collected by the MAKO 7 in Determining the Presence of Malignancy
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019



Intervention Details:
  • Device: Hysteroscopic cell sampling of the fallopian tube
    Hysteroscopic fallopian tube biopsy
    Other Name: MAKO 7


Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: Two weeks after receiving pathology report from clinical site ]
    Evaluate the sensitivity and specificity of the cytological samples collected from the fallopian tube in determining the presence or absence of malignancy for fallopian tube involvement as compared to the surgical histology results.


Secondary Outcome Measures :
  1. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement [ Time Frame: Two weeks after receiving pathology report from clinical site ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for MAKO 7 as compared to surgical histology of the ovaries and fallopian tube for fallopian tube involvement.

  2. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube [ Time Frame: Two weeks after receiving pathology report from clinical site ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for MAKO 7 as compared to surgical histology of the fallopian tube.

  3. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries [ Time Frame: Two weeks after receiving pathology report from clinical site ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for MAKO 7 as compared to surgical histology of the ovaries for epithelial malignancies.

  4. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis [ Time Frame: Two weeks after receiving pathology report from clinical site ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for MAKO 7 as compared to surgical histology for fallopian tube involvement subject level analysis.


Biospecimen Retention:   Samples With DNA
Tissue and Cells


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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
Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.
Criteria

Inclusion Criteria:

  1. Subject is medically cleared for surgery
  2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
  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
  7. Tubal ligation
  8. Invasive carcinoma of the cervix or endometrium
  9. 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): NCT03593681


Contacts
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Contact: Surbhi Sarna 408-655-3577 clin0507@nvisionmedical.com

Locations
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United States, California
Scripps Clinic Medical Group Recruiting
San Diego, California, United States, 92103
Contact: Anushree Singh    858-764-3023    singh.anushree@scrippshealth.org   
Contact: Bruce Kahn, MD    (858) 764-3225    Kahn.Bruce@scrippshealth.org   
Principal Investigator: Bruce Kahn, MD         
Kaiser Permanente San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Jia Wu, PhD    415-833-3480    Jia.X.Wu@kp.org   
Principal Investigator: Bethan Powell, MD         
Sub-Investigator: Ramey Littel, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Rachel Pung Page    904-953-8513    white.rachel2@mayo.edu   
Principal Investigator: Tri Dinh, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Maureen Lemens, RN, CCRA    507-293-1487    Lemens.maureen@mayo.edu   
Principal Investigator: Daniel Breitkopf, MD         
United States, New York
NYU Langone Laura and Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Allison Zambardino    212-263-4423    Allison.Zambardino@nyulangone.org   
Principal Investigator: Doug Levine, M.D.         
New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Reena Vattakalam    212-342-6895    rmv2110@cumc.columbia.edu   
Principal Investigator: Jason Wright, MD         
United States, Pennsylvania
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Charlotte Roberts, MA    215-829-7633    Charlotte.Roberts@uphs.upenn.edu   
Principal Investigator: Sarah H Kim, MD, MSCE         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Edwina McNeill-Simaan, MSHS, CCRC    615-343-9933    Edwina.o.mcneill-simaan@vumc.org   
Principal Investigator: Ted L Anderson, MD,PhD,FACOG         
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Tiffany Thomas, BSN, RN    214-648-7094    tiffany.thomas@utsouthwestern.edu   
Principal Investigator: David Miller, MD, FACOG         
Baylor Scott & White Research Institute Recruiting
Fort Worth, Texas, United States, 76104
Contact: Theresa Cheyne, RN    817-922-2579    Theresa.cheyne@bswhealth.org   
Principal Investigator: Delbert A Johns, MD,PhD,FACOG         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachel Lacy    434-924-8660    RMC9P@hscmail.mcc.virginia.edu   
Principal Investigator: Charles Landen, MD         
Sub-Investigator: Kari Ring, MD         
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98104
Contact: Erik Bailey    206-215-2397    erik.bailey@swedish.org   
Principal Investigator: Charles W Drescher, MD         
Sponsors and Collaborators
nVision Medical
Boston Scientific Corporation
Investigators
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Principal Investigator: Ted L Anderson, MD,PhD,FACOG Vanderbilt University Medical Center

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Responsible Party: nVision Medical
ClinicalTrials.gov Identifier: NCT03593681     History of Changes
Other Study ID Numbers: CLIN 0507
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by nVision Medical:
salpingo-oophorectomy
salpingectomy
ovarian cancer
fallopian tube cancer
high grade serous carcinoma
hysteroscopic biopsy
fallopian tube cell collection
peritoneal cancer
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Cystadenocarcinoma, Serous
Ovarian Diseases
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous