BRCA1 MutationNCT02974842
Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by nVision Medical at 3 sites in United States.
Trial summary
This study evaluates the ability of the MAKO 7 device to collect various cells Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation, Atypia Suspicious for Malignancy
- What is being tested?
- MAKO 7
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2016to 27 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put them at high risk of developing malignancy.
Who may be able to join
- Subject is medically cleared for surgery
- Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
- Subject must be 18 years of age
- Subject must be able to provide informed consent
Who cannot join
- 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 including tubal ligation
- Invasive carcinoma of the cervix or endometrium
- Intolerance of anesthesia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
Kaiser Permanente
San Francisco, California, 94115
Kaiser Permanente
Walnut Creek, California, 94596
About this study
Official title: 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
This study evaluates the ability of the MAKO 7 device to collect various cells
Read the 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.
- Being tested
- MAKO 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAKO 7Device
Hysteroscopic cell sampling
| Study group | Role | What they receive |
|---|---|---|
| Pre-Salpingo-Oophorectomy | Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy. Receives: Device: MAKO 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start2 Nov 2016
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- nVision Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Surbhi Sarna, B.S., Study director, nVision Medical Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974842
- Sponsor's protocol ID
- CLIN 0276
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2016
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02974842
- Acronym / sponsor ID
- CLIN 0276
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- nVision MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Salpingo-Oophorectomy | – | Device: MAKO 7Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put them at high risk of developing malignancy.
Key inclusion criteria (4 listed)
- Subject is medically cleared for surgery
- Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
- Subject must be 18 years of age
- Subject must be able to provide informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAKO 7Hysteroscopic cell sampling | Device | Pre-Salpingo-Oophorectomy |
Primary outcome
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surbhi Sarna, B.S. study director
nVision Medical Corp
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by nVision Medical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. (time frame: Up to 60 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.