Clinical trial NCT03892980: Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
Official title: A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nipple Sparing Mastectomy
Keywords: breast
robot
robotic
nipple sparing mastectomy
NSM
da Vinci
surgery
mastectomy
prophylactic NSM
risk reducing
BRCA mutation
nipple areola complex
NAC
RNSM
high-risk genetic mutation
gene mutation
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness: No conversions to open NSM
timeFrame: Assessed during surgery
measure: Primary Safety: Incidence of adverse events
timeFrame: Assessed during surgery to 42 days after surgery
Secondary outcomes:
Other outcomes:
measure: Incidence of breast cancer
timeFrame: Annual through 5 year post-operatively
measure: Patient reported outcomes
timeFrame: Pre-operatively, post-operatively at 42 days, annually through 5 years
measure: Long-term safety: incidence of adverse events
timeFrame: Annually through 5 years post-operatively
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: