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Robotic vs. Open NSM for Early Stage Breast Cancer (SP NSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05720039
Recruitment Status : Recruiting
First Posted : February 9, 2023
Last Update Posted : March 8, 2024
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Breast Cancer Breast Cancer, Early-Onset Breast Disease Breast Device: Robotic NSM Procedure: Open NSM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
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
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Robotic NSM with da Vinci SP
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Device: Robotic NSM
Robotic-assisted Nipple sparing mastectomy procedures
Other Names:
  • RNSM
  • SP NSM

Active Comparator: Open NSM
Subjects randomized to this arm will undergo conventional open NSM procedures
Procedure: Open NSM
open nipple-sparing mastectomy procedures




Primary Outcome Measures :
  1. Conversion rate [ Time Frame: Assessed during procedure ]
    Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery

  2. Safety: Adverse event rates [ Time Frame: Up to 42 days post-operatively ]
    Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM

  3. Safety: positive surgical margin rates [ Time Frame: Up to 42 days post-operatively ]
    Incidence of positive surgical margins compared to open NSM


Secondary Outcome Measures :
  1. Oncological Outcomes (for cancer recurrence) [ Time Frame: Up to 5 years ]
    Recurrence

  2. Oncological Outcomes (for disease-free survival) [ Time Frame: Up to 5 years ]
    Disease-free survival

  3. Oncological Outcomes (for overall survival) [ Time Frame: Up to 5 years ]
    Overall survival

  4. Patient-Report Outcomes (BREAST-Q) [ Time Frame: Up to 5 years ]
    BREAST-Q

  5. Patient-Report Outcomes (NAC Questionnaire) [ Time Frame: Up to 5 years ]
    NAC Questionnaire

  6. Patient-Report Outcomes (EQ-5D) [ Time Frame: Up to 1 year ]
    EQ-5D



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05720039


Contacts
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Contact: Kathryn Wine 415-990-4104 Kathryn.Wine@Intusurg.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Jennifer Tseng, MD    949-671-4673    jetseng@coh.org   
Contact: Stephanie Casal, MS, RN, CNS    949-671-4112    scasal@coh.org   
Principal Investigator: Jennifer Tseng, MD         
Sub-Investigator: Jamie Rand, MD         
Sub-Investigator: Mouchammed Agko, MD         
Sub-Investigator: Antoine Carre, MD         
Sub-Investigator: Katharine Schulz-Costello, DO         
Cedars-Sinai Recruiting
Los Angeles, California, United States, 940048
Contact: Farin Amersi, MD       farin.amersi@cshs.org   
Principal Investigator: Farin Amersi, MD         
Sub-Investigator: Alice Chung, MD         
Sub-Investigator: Kjirsten Carlson, MD         
Sub-Investigator: Marissa Boyle, MD         
Sub-Investigator: Edward Ray, MD         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Adna Makerevic    904-953-4248    dlflabreastcoords@mayo.edu   
Principal Investigator: James Jakub, MD         
Sub-Investigator: Brian Rinker, MD         
Sub-Investigator: Sarah McLaughlin, MD         
Sub-Investigator: Olivia Ho, MD         
Sub-Investigator: Tammeza Gibson, PA         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30342
Contact: Cathy Graham, MD       cathy.graham@emory.edu   
Principal Investigator: Cathy Graham, MD         
Sub-Investigator: Clara Farley, MD         
Sub-Investigator: Sarah Apatov, PA         
Sub-Investigator: Peter Thompson, MD         
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Duanny Alva    847-570-1783    dalva@northshore.org   
Contact: Anne Jankowski    847-570-1512    ajankowski@northshore.org   
Principal Investigator: Katherine Kopkash, MD         
United States, Michigan
Corewell Not yet recruiting
Detroit, Michigan, United States, 48073
Contact: Nayana Dekhne, MD       nayana.dekhne@corewellhealth.org   
Contact: Jesse Selber, MD       jesse.selber@corewellhealth.org   
Principal Investigator: Nayana Dekhne, MD         
Principal Investigator: Jesse Selber, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55902
Contact: Mara Piltin, DO    507-284-3975      
Contact: Clinical Coordinator    507-284-4432    bmsoresearch@mayo.edu   
Principal Investigator: Mara Piltin, DO         
United States, Missouri
Washington University, St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rebecca Aft, MD    314-747-0063    aftr@wustl.edu   
Principal Investigator: Rebecca Aft, MD         
Sub-Investigator: Joani Christensen, MD         
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Sabah Iqbal    516-881-7026    siqbal14@northwell.edu   
Principal Investigator: Alan Kadison, MD         
Sub-Investigator: Gary Deutsche, MD         
Sub-Investigator: Neil Tanna, MD         
Sub-Investigator: Armen Kasabian, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Kimberly Turnage, MSN       kimberly.turnage@duke.edu   
Contact: Adi Molvin    919-681-5908    adi.molvin@duke.edu   
Principal Investigator: Akiko Chiba, MD         
Sub-Investigator: Shelley Hwang, MD         
Sub-Investigator: Laura Rosenberger, MD         
Sub-Investigator: Geoffrey Sisk, MD         
Sub-Investigator: Rebecca Knackstedt, MD         
Sub-Investigator: Maggie Dinome, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Juliana Ruiz       juliana.ruiz@pennmedicine.upenn.edu   
Principal Investigator: Ari Brooks, MD         
United States, Tennessee
Vanderbilt Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Kathy Taylor         
Contact: Kelly Hewitt, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: John Tran    713-745-3759    jtran10@mdanderson.org   
Principal Investigator: Rosa Hwang, MD         
Sub-Investigator: Solange Cox, MD         
Sub-Investigator: Renee Largo, MD         
Sub-Investigator: Joani Christensen, MD         
Sub-Investigator: John Shuck, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Erin Fannon       ecarney@uw.edu   
Contact: Sara Javid, MD       sjavid@uv.edu   
Principal Investigator: Sara Javid, MD         
Sub-Investigator: Meghan Flanagan, MD         
Sub-Investigator: Suzanne Marie Inchauste, MD         
United States, Wisconsin
Ascension St. Columbia Mary's Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Alysandra Lal, MD       alysandralal@gmail.com   
Principal Investigator: Alysandra Lal, MD         
Sub-Investigator: John Yousif, MD         
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Study Director: Kathryn Wine Intuitive Surgical
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT05720039    
Other Study ID Numbers: ISI dV SP - NSM-01
First Posted: February 9, 2023    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Intuitive Surgical:
robotic
NSM
Nipple sparing mastectomy
da Vinci
breast cancer
mastectomy
breast
USA
robot
SP System
Single-port
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases