Clinical trial NCT05720039: Robotic vs. Open NSM for Early Stage Breast Cancer
Official title: A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer
Breast Cancer, Early-Onset
Breast Disease
Breast
Keywords: robotic
NSM
Nipple sparing mastectomy
da Vinci
breast cancer
mastectomy
breast
USA
robot
SP System
Single-port
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 204
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Conversion rate
timeFrame: Assessed during procedure
measure: Safety: Adverse event rates
timeFrame: Up to 42 days post-operatively
measure: Safety: positive surgical margin rates
timeFrame: Up to 42 days post-operatively
Secondary outcomes:
measure: Oncological Outcomes (for cancer recurrence)
timeFrame: Up to 5 years
measure: Oncological Outcomes (for disease-free survival)
timeFrame: Up to 5 years
measure: Oncological Outcomes (for overall survival)
timeFrame: Up to 5 years
measure: Patient-Report Outcomes (BREAST-Q)
timeFrame: Up to 5 years
measure: Patient-Report Outcomes (NAC Questionnaire)
timeFrame: Up to 5 years
measure: Patient-Report Outcomes (EQ-5D)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
city: Detroit
country: United States
facility: Corewell
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St. Louis
country: United States
facility: Washington University, St. Louis
state: Missouri
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Ascension St. Columbia Mary's
state: Wisconsin
Study officials:
affiliation: Intuitive
name: Madhu Gorrepati
role: STUDY_DIRECTOR
References: