Robotic-assisted nipple-sparing mastectomy procedure
A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
This study is testing a robotic surgery method to see if it can safely remove breast tissue while keeping the nipple and breast shape for women at high risk for breast cancer or those with cancer in one breast.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Intuitive Surgical Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Jacksonville, Florida and 5 other locations) |
| Trial ID | NCT03892980 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in performing prophylactic nipple-sparing mastectomy (NSM) procedures. The approach aims to preserve the shape of the breast and the nipple-areola complex while reducing the risk of breast cancer. Eligible participants include women at increased risk for breast cancer or those with breast cancer in one breast seeking surgery on the other side. The study will assess outcomes related to the surgical technique and patient recovery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-80 with a BMI of 29 or less, at increased risk for breast cancer, and seeking prophylactic nipple-sparing mastectomy.
Not a fit: Patients with a history of breast cancer in the breast undergoing surgery or those with uncontrolled diabetes or significant skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a less invasive surgical option for women at high risk of breast cancer, improving cosmetic outcomes and potentially reducing recovery time.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgical techniques, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida and 5 other locations
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
- NorthShore University Health System — Evanston, Illinois, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Northwell Health — New Hyde Park, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Tish Mikoczi
- Email: NSM-Xi@intusurg.com
- Phone: 760-274-5811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.