Trial Title:
Robotic Vs. Open NSM for Early Stage Breast Cancer
NCT ID:
NCT05720039
Condition:
Breast Cancer Female
Breast Cancer
Breast Cancer, Early-Onset
Breast Disease
Breast
Conditions: Official terms:
Breast Neoplasms
Breast Diseases
Conditions: Keywords:
robotic
NSM
Nipple sparing mastectomy
da Vinci
breast cancer
mastectomy
breast
USA
robot
SP System
Single-port
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP
Surgical System or open NSM
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Robotic NSM
Description:
Robotic-assisted Nipple sparing mastectomy procedures
Arm group label:
Robotic NSM with da Vinci SP
Other name:
RNSM
Other name:
SP NSM
Intervention type:
Procedure
Intervention name:
Open NSM
Description:
open nipple-sparing mastectomy procedures
Arm group label:
Open NSM
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.
Criteria for 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
Gender:
Female
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Cedars-Sinai
Address:
City:
Los Angeles
Zip:
940048
Country:
United States
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Facility:
Name:
NorthShore University HealthSystem
Address:
City:
Evanston
Zip:
60201
Country:
United States
Facility:
Name:
Corewell
Address:
City:
Detroit
Zip:
48073
Country:
United States
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55902
Country:
United States
Facility:
Name:
Washington University, St. Louis
Address:
City:
St. Louis
Zip:
63110
Country:
United States
Facility:
Name:
Northwell Health
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Facility:
Name:
Vanderbilt
Address:
City:
Nashville
Zip:
37232
Country:
United States
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
University of Washington
Address:
City:
Seattle
Zip:
98195
Country:
United States
Facility:
Name:
Ascension St. Columbia Mary's
Address:
City:
Milwaukee
Zip:
53211
Country:
United States
Start date:
May 8, 2023
Completion date:
December 2030
Lead sponsor:
Agency:
Intuitive Surgical
Agency class:
Industry
Source:
Intuitive Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720039
