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

Intuitive Surgical

Status: Terminated

Conditions: Prophylactic Nipple Sparing Mastectomy (NSM)

Treatments: Procedure: Nipple-Sparing Mastectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT05251285

PN #1082409C

Details and patient eligibility

About

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.

Full description

This is an observational post-market study. Women will be screened for participation where the decision to undergo prophylactic R-NSM surgery has already been made as part of their medical care. In order for women to be enrolled, surgeons must perform the surgery according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System. Women will sign an informed consent form for their participation in the study. Women will be prospectively followed at 6 weeks, 3 months and 1 year post-surgery, which is within the standard of care. Data will be collected prospectively from the medical records and women will be asked to complete preoperative and postoperative questionnaires.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

7 participants in 1 patient group

Prophylactic Nipple-Sparing Mastectomy

Treatment:

Procedure: Nipple-Sparing Mastectomy