TerminatedNot Applicable

Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

Stopped: Low enrolment

France, Italy7 participantsStarted 2022-01-18

Plain-language summary

The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is a woman, candidate for a prophylactic R-NSM surgical procedure (unilateral or bilateral) according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System * Subject has cup size A, B or C, * Subject is 18 years of age or older, * Subject is a candidate for reconstruction, * Subject is willing to participate as demonstrated by signing the informed consent, * Subject benefits from a health care system/insurance. Exclusion Criteria: * Subject is pregnant or is lactating, * Subject has active cancer or pre-cancer (Ductal Carcinoma In Situ \[DCIS\]) on breast to be robotically operated, * Subject has cancer involving the Nipple Areolar Complex (NAC), inflammatory breast cancer or T4d lesion, clinical evidence of skin involvement or T4b lesion, and clinical or radiological evidence of chest wall invasion. * Subject has ASA score ˃ III or has known thromboembolism risks or, is at risk in relation to anesthesia, * Subject presents severe lack of cooperation due to psychological or severe systemic illness, * Subject has medical conditions contraindicating general anesthesia or surgical approach, * Subject is part of vulnerable population (e.g., prisoners, mentally disabled).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of intraoperative R-NSM procedure and device-related complications

Timeframe: Assessed during surgery to 42 days after surgery

Number of overall post-operative complications at 6 weeks

Timeframe: 6 weeks after the surgery

Number of overall post-operative complications at 3 months

Timeframe: 3 months after the surgery

Number of overall post-operative complications at 1 year

Timeframe: 1 year after the surgery

Nipple-Areola Complex (NAC) necrosis occurrence (using SKIN composite score definition of D2 or higher) observed at 6 weeks after surgery

Timeframe: 6 weeks after surgery

Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery

Timeframe: 6 weeks after surgery

Number of conversions to open surgery

Timeframe: Assessed during surgery

Trial details

NCT IDNCT05251285

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-18

View on ClinicalTrials.gov More Prophylactic Nipple Sparing Mastectomy (NSM) trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of intraoperative R-NSM procedure and device-related complications

Timeframe: Assessed during surgery to 42 days after surgery

Number of overall post-operative complications at 6 weeks

Timeframe: 6 weeks after the surgery

Number of overall post-operative complications at 3 months

Timeframe: 3 months after the surgery

Number of overall post-operative complications at 1 year

Timeframe: 1 year after the surgery

Nipple-Areola Complex (NAC) necrosis occurrence (using SKIN composite score definition of D2 or higher) observed at 6 weeks after surgery

Timeframe: 6 weeks after surgery

Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery

Timeframe: 6 weeks after surgery

Number of conversions to open surgery

Timeframe: Assessed during surgery