Robotic vs. Open NSM for Early Stage Breast Cancer

N/AActive Not RecruitingNCT05720039

Intuitive Surgical204 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Breast Cancer Female Breast Cancer Breast Cancer, Early-Onset Breast Disease Breast

Interventions

Robotic NSMDEVICE

Robotic-assisted Nipple sparing mastectomy procedures

Open NSMPROCEDURE

open nipple-sparing mastectomy procedures

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (15)

City of Hope

Irvine, California, United States

Cedars-Sinai

Los Angeles, California, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Conversion rate

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

Time frame: Assessed during procedure

Safety: Adverse event rates

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

Time frame: Up to 42 days post-operatively

Safety: positive surgical margin rates

Incidence of positive surgical margins compared to open NSM

Time frame: Up to 42 days post-operatively

Secondary Outcomes

Oncological Outcomes (for cancer recurrence)

Recurrence

Time frame: Up to 5 years

Oncological Outcomes (for disease-free survival)

Disease-free survival

Time frame: Up to 5 years

Oncological Outcomes (for overall survival)

Overall survival

Time frame: Up to 5 years

Patient-Report Outcomes (BREAST-Q)

BREAST-Q

Time frame: Up to 5 years

Patient-Report Outcomes (NAC Questionnaire)

NAC Questionnaire

Time frame: Up to 5 years

Patient-Report Outcomes (EQ-5D)

EQ-5D

Data from ClinicalTrials.gov

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