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This study evaluates the ability of the MAKO 7 device to collect various cells
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Salpingo-Oophorectomy | Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAKO 7 | Device | Hysteroscopic cell sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | 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. | Up to 60 days post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put them at high risk of developing malignancy.
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| Name | Affiliation | Role |
|---|---|---|
| Surbhi Sarna, B.S. | nVision Medical Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | San Francisco | California | 94115 | United States | ||
| Kaiser Permanente |
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This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.
Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation were recruited from three gynecologic oncology centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAKO 7 Group | Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eligible Participants With Hysteroscopic Attempt | Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | 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. | Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results. | Posted | Count of Units | fallopian tubes | Up to 60 days post-operatively | fallopian tubes | fallopian tubes |
|
Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MAKO 7 Group | Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine perforation | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Surbhi Sarna | nVision Medical | 408 655 3577 | surbhi@nvisionmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Mar 27, 2020 | Prot_SAP_000.pdf |
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Cell samples
| Walnut Creek |
| California |
| 94596 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Reason for Surgery | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| fallopian tubes |
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 25 |
| 42 |
| Nausea | General disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Pain | Surgical and medical procedures | Systematic Assessment | Not related to study procedure or study device |
|
| Dizziness | General disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Fatigue | General disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Hypotension | General disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Hematological Dyscrasia | Blood and lymphatic system disorders | Systematic Assessment | Not related to study procedure or study device |
|
| Electrolyte Imbalance | General disorders | Systematic Assessment | Not related to study procedure or study device |
|
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