Clinical trial · Observational
Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
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
NCT02974842CI-TRIAL-00044754completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the ability of the MAKO 7 device to collect various cells
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypia Suspicious for Malignancy | — | UNRESOLVED | — |
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAKO 7 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pre-Salpingo-Oophorectomy
- description
- Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.
- interventionNames
- Device: MAKO 7
Primary outcomes (1)
- measure
- Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
- timeFrame
- Up to 60 days post-operatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.