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OpenTrials
Active, Not Recruiting

NCT Number: NCT05720039

Robotic vs. Open NSM for Early Stage Breast Cancer

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Female Breast Breast Cancer Breast Cancer, Early-Onset Breast Disease Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope, Irvine, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic NSM

Device

Robotic-assisted Nipple sparing mastectomy procedures

Other names: RNSM, SP NSM

Open NSM

Procedure

open nipple-sparing mastectomy procedures

Primary outcomes

  1. Conversion rate

    Time frame: Assessed during procedure

    Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery

  2. Safety: Adverse event rates

    Time frame: Up to 42 days post-operatively

    Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM

  3. Safety: positive surgical margin rates

    Time frame: Up to 42 days post-operatively

    Incidence of positive surgical margins compared to open NSM

Secondary outcomes

  1. Oncological Outcomes (for cancer recurrence)

    Time frame: Up to 5 years

    Recurrence

  2. Oncological Outcomes (for disease-free survival)

    Time frame: Up to 5 years

    Disease-free survival

  3. Oncological Outcomes (for overall survival)

    Time frame: Up to 5 years

    Overall survival

  4. Patient-Report Outcomes (BREAST-Q)

    Time frame: Up to 5 years

    BREAST-Q

  5. Patient-Report Outcomes (NAC Questionnaire)

    Time frame: Up to 5 years

    NAC Questionnaire

  6. Patient-Report Outcomes (EQ-5D)

    Time frame: Up to 1 year

    EQ-5D

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Acronym: SP NSM

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Feb 9, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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