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Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy

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: NCT03892980
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

Brief Summary:
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Condition or disease Intervention/treatment Phase
Nipple Sparing Mastectomy Device: Nipple-Sparing Mastectomy Not Applicable

Detailed Description:

Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.

This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : December 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Nipple Sparing Mastectomy Device: Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.




Primary Outcome Measures :
  1. Primary Effectiveness: No conversions to open NSM [ Time Frame: Assessed during surgery ]
    Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery

  2. Primary Safety: Incidence of adverse events [ Time Frame: Assessed during surgery to 42 days after surgery ]
    Incidence of intraoperative and post-operative procedure and device-related adverse events


Other Outcome Measures:
  1. Incidence of breast cancer [ Time Frame: Annual through 5 year post-operatively ]
    Occurrence and recurrence of breast cancer

  2. Patient reported outcomes [ Time Frame: Pre-operatively, post-operatively at 42 days, annually through 5 years ]
    BREAST-Q

  3. Long-term safety: incidence of adverse events [ Time Frame: Annually through 5 years post-operatively ]
    Incidence of breast procedure-related adverse events during long-term follow up



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:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female between ages 18-80.
  • BMI ≤ 29.
  • Candidate for an NSM procedure.
  • At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
  • Breast ptosis ≤ Grade 2.
  • Cup size ≤ C.
  • No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines.

Exclusion Criteria:

  • Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery.
  • Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
  • Current history of smoking or has smoked within 1 year of screening.
  • Skin conditions
  • Uncontrolled diabetes mellitus.
  • Previous chemotherapy or radiation
  • High risk for anesthesia or significant medical comorbidities
  • Contraindicated for general anesthesia or surgery.
  • Known bleeding or clotting disorder.
  • Pregnant or suspected to be pregnant or is lactating.

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): NCT03892980


Contacts
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Contact: Tish Mikoczi 760-274-5811 NSM-Xi@intusurg.com

Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Amanda Arnold    904-953-4248    DLFLABreastCoords@mayo.edu   
Principal Investigator: James Jakub, MD         
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Anne Jankowski, MPH    847-570-1512    ajankowski@northshore.org   
Contact: Kayla Gray    847-570-1184    Kgray3@northshore.org   
Principal Investigator: Katherine Kopkash, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennie Musty    507-538-4849    BMSORESEARCH@mayo.edu   
Contact: Amy Holst    507-266-0962    Musty.Jennie@mayo.edu   
Principal Investigator: Mara Piltin, DO         
United States, New York
Northwell Health Recruiting
New Hyde Park, New York, United States, 11040
Contact: Kirendra Pasram    516-881-7026      
Principal Investigator: Alan Kadison, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Ari Brooks, MD    215-829-8461    Ari.Brooks@pennmedicine.upenn.edu   
Contact: Juliana Ruiz    215-327-9164    Juliana.Ruiz@Pennmedicine.upenn.edu   
Principal Investigator: Ari Brooks, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rosa Hwang, M.D.    713-563-1873      
Contact: John Tran, B.S.    713-745-3759      
Principal Investigator: Rosa Hwang, MD         
Sponsors and Collaborators
Intuitive Surgical
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03892980    
Other Study ID Numbers: ISI dV Xi-NSM
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 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:
breast
robot
robotic
nipple sparing mastectomy
NSM
da Vinci
surgery
mastectomy
prophylactic NSM
risk reducing
BRCA mutation
nipple areola complex
NAC
RNSM
high-risk genetic mutation
gene mutation