Trials / Active Not Recruiting
Active Not RecruitingNCT03892980
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Detailed description
Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex. This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Nipple-Sparing Mastectomy | Nipple-sparing mastectomy using da Vinci Surgical Systems. |
Timeline
- Start date
- 2021-03-26
- Primary completion
- 2027-04-30
- Completion
- 2029-12-30
- First posted
- 2019-03-27
- Last updated
- 2025-12-18
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03892980. Inclusion in this directory is not an endorsement.