Atypia Suspicious for Malignancy, BRCA1 Mutation, BRCA2 Mutation
Conditions
Brief summary
This study evaluates the ability of the MAKO 7 device to collect various cells
Detailed description
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.
Interventions
DEVICEMAKO 7
Hysteroscopic cell sampling
Sponsors
nVision Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | Up to 60 days post-operatively | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.
Participants by arm
| Arm | Count |
|---|---|
| Eligible Participants With Hysteroscopic Attempt Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen failures | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Eligible Participants With Hysteroscopic Attempt |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 15.7 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 29 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic or non-Latino | 3 Participants |
| Reason for Surgery BRCA 1 or BRCA 2 mutations | 8 Participants |
| Reason for Surgery Pelvic mass suspicious for malignancy | 34 Participants |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 25 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
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.
Time frame: Up to 60 days post-operatively
Population: Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MAKO 7 Group | Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | Discordant | 2 fallopian tubes |
| MAKO 7 Group | Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | Concordant | 42 fallopian tubes |