Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
NCT03892980 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2025-12-18
Summary
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Conditions
- Nipple Sparing Mastectomy
Interventions
- DEVICE
-
Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.
Sponsors & Collaborators
-
Intuitive Surgical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-26
- Primary Completion
- 2027-04-30
- Completion
- 2029-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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