NCT02974842

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: nVision Medical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BRCA1 Mutation
• BRCA2 Mutation
• Atypia Suspicious for Malignancy

Interventions

Type	Name	Description
DEVICE	MAKO 7	Hysteroscopic cell sampling

Timeline

• Start date: 2016-11-02
• Primary completion: 2017-09-27
• Completion: 2017-09-27
• First posted: 2016-11-29
• Last updated: 2020-04-21
• Results posted: 2020-04-09

Locations

3 sites across 1 country: United States