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Robotic vs. Open NSM for Early Stage Breast Cancer

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic NSM
Open NSM
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • Cedars-SinaiRecruiting
  • Mayo Clinic FloridaRecruiting
  • Emory University
  • NorthShore University HealthSystemRecruiting
  • Corewell
  • Mayo Clinic RochesterRecruiting
  • Washington University, St. LouisRecruiting
  • Northwell HealthRecruiting
  • Duke UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Washington
  • Ascension St. Columbia Mary'sRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic NSM with da Vinci SP

Open NSM

Arm Description

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Subjects randomized to this arm will undergo conventional open NSM procedures

Outcomes

Primary Outcome Measures

Conversion rate
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Safety: Adverse event rates
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Safety: positive surgical margin rates
Incidence of positive surgical margins compared to open NSM

Secondary Outcome Measures

Oncological Outcomes (for cancer recurrence)
Recurrence
Oncological Outcomes (for disease-free survival)
Disease-free survival
Oncological Outcomes (for overall survival)
Overall survival
Patient-Report Outcomes (BREAST-Q)
BREAST-Q
Patient-Report Outcomes (NAC Questionnaire)
NAC Questionnaire
Patient-Report Outcomes (EQ-5D)
EQ-5D

Full Information

First Posted
January 17, 2023
Last Updated
October 16, 2023
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT05720039
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset
Keywords
robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic NSM with da Vinci SP
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Arm Title
Open NSM
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will undergo conventional open NSM procedures
Intervention Type
Device
Intervention Name(s)
Robotic NSM
Other Intervention Name(s)
RNSM, SP NSM
Intervention Description
Robotic-assisted Nipple sparing mastectomy procedures
Intervention Type
Procedure
Intervention Name(s)
Open NSM
Intervention Description
open nipple-sparing mastectomy procedures
Primary Outcome Measure Information:
Title
Conversion rate
Description
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Time Frame
Assessed during procedure
Title
Safety: Adverse event rates
Description
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Time Frame
Up to 42 days post-operatively
Title
Safety: positive surgical margin rates
Description
Incidence of positive surgical margins compared to open NSM
Time Frame
Up to 42 days post-operatively
Secondary Outcome Measure Information:
Title
Oncological Outcomes (for cancer recurrence)
Description
Recurrence
Time Frame
Up to 5 years
Title
Oncological Outcomes (for disease-free survival)
Description
Disease-free survival
Time Frame
Up to 5 years
Title
Oncological Outcomes (for overall survival)
Description
Overall survival
Time Frame
Up to 5 years
Title
Patient-Report Outcomes (BREAST-Q)
Description
BREAST-Q
Time Frame
Up to 5 years
Title
Patient-Report Outcomes (NAC Questionnaire)
Description
NAC Questionnaire
Time Frame
Up to 5 years
Title
Patient-Report Outcomes (EQ-5D)
Description
EQ-5D
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Wine
Phone
415-990-4104
Email
Kathryn.Wine@Intusurg.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Wine
Organizational Affiliation
Intuitive Surgical
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Tseng, MD
Phone
949-671-4673
Email
jetseng@coh.org
First Name & Middle Initial & Last Name & Degree
Stephanie Casal, MS, RN, CNS
Phone
949-671-4112
Email
scasal@coh.org
First Name & Middle Initial & Last Name & Degree
Jennifer Tseng, MD
First Name & Middle Initial & Last Name & Degree
Jamie Rand, MD
First Name & Middle Initial & Last Name & Degree
Mouchammed Agko, MD
First Name & Middle Initial & Last Name & Degree
Antoine Carre, MD
First Name & Middle Initial & Last Name & Degree
Katharine Schulz-Costello, DO
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
940048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farin Amersi, MD
Email
farin.amersi@cshs.org
First Name & Middle Initial & Last Name & Degree
Farin Amersi, MD
First Name & Middle Initial & Last Name & Degree
Alice Chung, MD
First Name & Middle Initial & Last Name & Degree
Kjirsten Carlson, MD
First Name & Middle Initial & Last Name & Degree
Marissa Boyle, MD
First Name & Middle Initial & Last Name & Degree
Edward Ray, MD
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adna Makerevic
Phone
904-953-4248
Email
dlflabreastcoords@mayo.edu
First Name & Middle Initial & Last Name & Degree
James Jakub, MD
First Name & Middle Initial & Last Name & Degree
Brian Rinker, MD
First Name & Middle Initial & Last Name & Degree
Sarah McLaughlin, MD
First Name & Middle Initial & Last Name & Degree
Olivia Ho, MD
First Name & Middle Initial & Last Name & Degree
Tammeza Gibson, PA
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Graham, MD
Email
cathy.graham@emory.edu
First Name & Middle Initial & Last Name & Degree
Cathy Graham, MD
First Name & Middle Initial & Last Name & Degree
Clara Farley, MD
First Name & Middle Initial & Last Name & Degree
Sarah Apatov, PA
First Name & Middle Initial & Last Name & Degree
Peter Thompson, MD
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duanny Alva
Phone
847-570-1783
Email
dalva@northshore.org
First Name & Middle Initial & Last Name & Degree
Anne Jankowski
Phone
847-570-1512
Email
ajankowski@northshore.org
First Name & Middle Initial & Last Name & Degree
Katherine Kopkash, MD
Facility Name
Corewell
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayana Dekhne, MD
Email
nayana.dekhne@corewellhealth.org
First Name & Middle Initial & Last Name & Degree
Jesse Selber, MD
Email
jesse.selber@corewellhealth.org
First Name & Middle Initial & Last Name & Degree
Nayana Dekhne, MD
First Name & Middle Initial & Last Name & Degree
Jesse Selber, MD
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Piltin, DO
Phone
507-284-3975
First Name & Middle Initial & Last Name & Degree
Clinical Coordinator
Phone
507-284-4432
Email
bmsoresearch@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mara Piltin, DO
Facility Name
Washington University, St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Aft, MD
Phone
314-747-0063
Email
aftr@wustl.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Aft, MD
First Name & Middle Initial & Last Name & Degree
Joani Christensen, MD
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabah Iqbal
Phone
516-881-7026
Email
siqbal14@northwell.edu
First Name & Middle Initial & Last Name & Degree
Alan Kadison, MD
First Name & Middle Initial & Last Name & Degree
Gary Deutsche, MD
First Name & Middle Initial & Last Name & Degree
Neil Tanna, MD
First Name & Middle Initial & Last Name & Degree
Armen Kasabian, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Turnage, MSN
Email
kimberly.turnage@duke.edu
First Name & Middle Initial & Last Name & Degree
Adi Molvin
Phone
919-681-5908
Email
adi.molvin@duke.edu
First Name & Middle Initial & Last Name & Degree
Akiko Chiba, MD
First Name & Middle Initial & Last Name & Degree
Shelley Hwang, MD
First Name & Middle Initial & Last Name & Degree
Laura Rosenberger, MD
First Name & Middle Initial & Last Name & Degree
Geoffrey Sisk, MD
First Name & Middle Initial & Last Name & Degree
Rebecca Knackstedt, MD
First Name & Middle Initial & Last Name & Degree
Maggie Dinome, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Ruiz
Email
juliana.ruiz@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ari Brooks, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Tran
Phone
713-745-3759
Email
jtran10@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Rosa Hwang, MD
First Name & Middle Initial & Last Name & Degree
Solange Cox, MD
First Name & Middle Initial & Last Name & Degree
Renee Largo, MD
First Name & Middle Initial & Last Name & Degree
Joani Christensen, MD
First Name & Middle Initial & Last Name & Degree
John Shuck, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Fannon
Email
ecarney@uw.edu
First Name & Middle Initial & Last Name & Degree
Sara Javid, MD
Email
sjavid@uv.edu
First Name & Middle Initial & Last Name & Degree
Sara Javid, MD
First Name & Middle Initial & Last Name & Degree
Meghan Flanagan, MD
First Name & Middle Initial & Last Name & Degree
Suzanne Marie Inchauste, MD
Facility Name
Ascension St. Columbia Mary's
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alysandra Lal, MD
Email
alysandralal@gmail.com
First Name & Middle Initial & Last Name & Degree
Alysandra Lal, MD
First Name & Middle Initial & Last Name & Degree
John Yousif, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Robotic vs. Open NSM for Early Stage Breast Cancer

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