N/A
Completed N=150
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
Fallopian tube cancer · Ovarian Cancer · Fallopian Tube Neoplasms · Fallopian Tube Adenocarcinoma
Source: ClinicalTrials.gov NCT03593681 ↗
Enrolled (actual)
150
Serious AEs
2.3%
Results posted
Jan 2021
Primary outcomePrimary: Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement — .143; .959 Proportion of Cytuity Cell Samples
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement |
.143; .959 | — |
| SECONDARY PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement |
0.221; 0.932; .894 | — |
| SECONDARY Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube |
.077; .952; .108; .932; .888 | — |
| SECONDARY Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries |
.091; .963; .281; .883; .851 | — |
| SECONDARY Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis |
2; 58; 2; 58; 60 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is medically cleared for surgery
- Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
- 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
- Tubal ligation
- Invasive carcinoma of the cervix or endometrium
- Intolerance of anesthesia
Data sourced from ClinicalTrials.gov (NCT03593681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.