Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

Not Applicable

Recruiting

• Conditions: Nipple Sparing Mastectomy
• Interventions: Device: Nipple-Sparing Mastectomy

• Registration Number: NCT03892980
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2021-03-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-04-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 145

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nipple Sparing Mastectomy	Nipple-Sparing Mastectomy	-

Primary Outcome Measures

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

Trial Locations

Locations (6)

Northwell Health; 🇺🇸 New Hyde Park, New York, United States

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States