Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
Running, not enrolling · Not applicable
Conditions studied: Nipple Sparing Mastectomy
In brief
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Key facts
- Study ID
- NCT03892980
- Run by
- Intuitive Surgical
- People needed
- 145
- Starts
- 2021-03-26
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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