Status:
TERMINATED
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
Lead Sponsor:
Intuitive Surgical
Conditions:
Prophylactic Nipple Sparing Mastectomy (NSM)
Eligibility:
FEMALE
18+ years
Brief 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...
Detailed 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 or...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 18 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05251285
Start Date
January 18 2022
End Date
July 18 2023
Last Update
December 22 2023
Active Locations (2)
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1
Gustave Roussy Cancer Campus
Villejuif, France, 94800
2
Istituto Europeo di Oncologia
Milan, Italy, 20141