NCT05251285

Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an observational post-market study. Women will be screened for participation where the decision to undergo prophylactic R-NSM surgery has already been made as part of their medical care. In order for women to be enrolled, surgeons must perform the surgery according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System. Women will sign an informed consent form for their participation in the study. Women will be prospectively followed at 6 weeks, 3 months and 1 year post-surgery, which is within the standard of care. Data will be collected prospectively from the medical records and women will be asked to complete preoperative and postoperative questionnaires.

Conditions

• Prophylactic Nipple Sparing Mastectomy (NSM)

Interventions

Type	Name	Description
PROCEDURE	Nipple-Sparing Mastectomy	Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2022-02-22
• Last updated: 2023-12-22

Locations

2 sites across 2 countries: France, Italy