Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

Intuitive Surgical

Status: Active, not recruiting

Conditions: Nipple Sparing Mastectomy

Treatments: Device: Nipple-Sparing Mastectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03892980

ISI dV Xi-SP NSM

Details and patient eligibility

About

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

Full 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.

Enrollment: 145 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Nipple Sparing Mastectomy

Experimental group

Treatment:

Device: Nipple-Sparing Mastectomy