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Robotic vs. Open NSM for Early Stage Breast Cancer

Robotic vs. Open NSM for Early Stage Breast Cancer

Recruiting
21 years and older
Female
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Description

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Eligibility

Inclusion Criteria:

  • Female age 21 or older
  • BMI < 30
  • Candidate for an NSM procedure with immediate reconstruction
  • Diagnosis of early stage brest cancer
  • Breast ptosis ≤ Grade 2.
  • Cup size ≤ C.

Exclusion Criteria:

  • Previous breast surgery
  • Diagnosis of metastatic breast cancer
  • Prior radiation treatment to the chest
  • Current smokers
  • Contraindication for general anesthesia or surgery.
  • Known bleeding or clotting disorder.
  • Pregnant or suspected to be pregnant, or actively breastfeeding

Study details
    Breast Cancer Female
    Breast Cancer
    Breast Cancer
    Early-Onset
    Breast Disease
    Breast

NCT05720039

Intuitive Surgical

4 May 2025

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