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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03593681
Other study ID # CLIN 0507
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 27, 2018
Est. completion date February 14, 2020

Study information

Verified date December 2020
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date February 14, 2020
Est. primary completion date February 14, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Hysteroscopic cell sampling of the fallopian tube
Hysteroscopic fallopian tube biopsy

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia
United States Baylor Scott & White Research Institute Fort Worth Texas
United States Mayo Clinic Jacksonville Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States New York Presbyterian Hospital New York New York
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Scripps Clinic Medical Group San Diego California
United States Kaiser Permanente San Francisco Medical Center San Francisco California
United States Swedish Health Services Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement 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. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube. At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries and fallopian tube for fallopian tube involvement. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube. At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the fallopian tube. At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries for epithelial malignancies. At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology for fallopian tube involvement at the subject level. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube. At the time of the scheduled salpingectomy or salpingo-oophorectomy
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