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

NCT05251285 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2023-12-22

No results posted yet for this study

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.

Conditions

  • Prophylactic Nipple Sparing Mastectomy (NSM)

Interventions

PROCEDURE

Nipple-Sparing Mastectomy

Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Antonio Toesca, MD · Istituto Europeo di Oncologia

  • Benjamin Sarfati, MD · Gustave Roussy Cancer Campus

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2023-07-18
Completion
2023-07-18

Countries

  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251285 on ClinicalTrials.gov