Robotic Nipple Sparing Mastectomy (NSM) Study | Clinical Research Studies Listing

Enrolling By Invitation

18-80 years

Female

Phase 3

50 participants needed

1 Location

Brief description of study

The goal of this prospective study is to evaluate the safety and effectiveness of the da Vinci Xi Surgical System, instruments, and accessories in Nipple Sparing Mastectomy, otherwise known as NSM procedures.

Detailed description of study

The primary effectiveness endpoint will evaluate the ability of the da Vinci Xi to complete the NSM procedure without converting to an open approach and the ability to preserve the NAC during the 42-day follow-up period. The primary safety endpoint will evaluate the incidence of intraoperative NSM procedure and device-related adverse events and all post-operative adverse events that occur through the 42-day follow-up period as compared to the published rates reported for open NSM procedures.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Mastectomy,Nipple Sparing Mastectomy (NSM),Prophylactic/Preventative NSM,BRCA 1/2 positive,genetic risk for breast cancer,high risk for breast cancer
Age: Between 18 Years - 80 Years
Gender: Female

Patients that meet the following criteria will be eligible to participate in the study:

1. A candidate for unilateral or bilateral nipple sparing mastectomy procedure with immediate reconstruction.

2. An increased risk for breast cancer and is seeking a prophylactic NSM surgery.

3. No presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution guidelines. Known carriers of pathogenic BRCA1/2 mutations should have a negative breast MRI.

4. A BMI of less than or equal to 29.

5. Breast ptosis is less than or equal to Grade 2.

6. Breast cup size is less than or equal to a C cup.

7. At a low to moderate risk for anesthesia.

8. Is willing and able to provide written informed consent.

9. Is willing and able to comply with the study protocol requirements including follow up examinations up to 5 years (+/- 90 days) post operatively.

Updated on 01 Aug 2024. Study ID: 834811

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