Stopped early
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
NCT05251285 · Intuitive Surgical · Updated 22 Dec 2023
- What is being tested
- Nipple-Sparing Mastectomy
- For
- Prophylactic Nipple Sparing Mastectomy (NSM)
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 7 people. The full rules are on the registry page.
- Where
- France, Italy (2 sites)
- When
- Starts or started 18 Jan 2022, ends 18 July 2023. Registered 22 Feb 2022.
- Results
- None posted yet.
In the researchers' words
The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.
Sites
- Gustave Roussy Cancer CampusVillejuif, France
- Istituto Europeo di OncologiaMilan, Italy