Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance

BRCA1 Mutation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974842
• Other study ID #: CLIN 0276
• Status: Completed
• Start date: November 2, 2016
• Est. completion date: September 27, 2017

Study information

• Verified date: April 2020
• Source: nVision Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the ability of the MAKO 7 device to collect various cells

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypia Suspicious for Malignancy
• BRCA1 Mutation
• BRCA2 Mutation
• Neoplasms

Intervention

Device:
• MAKO 7
Hysteroscopic cell sampling

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Kaiser Permanente	San Francisco	California
United States	Kaiser Permanente	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
nVision Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 60 days post-operatively