Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
NCT ID: NCT03892980
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
145 participants
INTERVENTIONAL
2021-03-26
2029-12-30
Brief Summary
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Detailed Description
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This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Nipple Sparing Mastectomy
Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.
Interventions
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Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
FEMALE
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
New Hyde Park, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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ISI dV Xi-SP NSM
Identifier Type: -
Identifier Source: org_study_id