Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy

A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Study Overview

• Status: Recruiting
• Conditions: Nipple Sparing Mastectomy
• Intervention / Treatment: Device: Nipple-Sparing Mastectomy

Detailed Description

Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.

This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.

• Study Type: Interventional
• Enrollment (Estimated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tish Mikoczi; Phone Number: 760-274-5811; Email: NSM-Xi@intusurg.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Amanda Arnold
      • Principal Investigator: James Jakub, MD
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University Health System
      • Contact: Sarah Rabbitt, RN
      • Principal Investigator: Katherine Kopkash, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Jennifer Krogman
      • Principal Investigator: Mara Piltin, DO
  • New York
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Northwell Health
      • Contact: Kirendra Pasram
      • Principal Investigator: Alan Kadison, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Ari Brooks, MD
      • Contact: Ari Brooks, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Rosa Hwang, MD
      • Principal Investigator: Rosa Hwang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female between ages 18-80.
• BMI ≤ 29.
• Candidate for an NSM procedure.
• At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
• Breast ptosis ≤ Grade 2.
• Cup size ≤ C.
• No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines.

Exclusion Criteria:

• Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery.
• Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
• Current history of smoking or has smoked within 1 year of screening.
• Skin conditions
• Uncontrolled diabetes mellitus.
• Previous chemotherapy or radiation
• High risk for anesthesia or significant medical comorbidities
• Contraindicated for general anesthesia or surgery.
• Known bleeding or clotting disorder.
• Pregnant or suspected to be pregnant or is lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nipple Sparing Mastectomy	Device: Nipple-Sparing Mastectomy; Nipple-sparing mastectomy using da Vinci Surgical Systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: Incidence of adverse events	Incidence of intraoperative and post-operative procedure and device-related adverse events	Assessed during surgery to 42 days after surgery
Primary Effectiveness: No conversions to open NSM	Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery	Assessed during surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of breast cancer	Occurrence and recurrence of breast cancer	Annual through 5 year post-operatively
Patient reported outcomes	BREAST-Q	Pre-operatively, post-operatively at 42 days, annually through 5 years
Long-term safety: incidence of adverse events	Incidence of breast procedure-related adverse events during long-term follow up	Annually through 5 years post-operatively

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: surgery; breast; BRCA mutation; robotic; robot; NAC; mastectomy; nipple sparing mastectomy; da Vinci; NSM; prophylactic NSM; gene mutation; risk reducing; nipple areola complex; RNSM; high-risk genetic mutation
• Other Study ID Numbers: ISI dV Xi-NSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes