Clinical trial NCT05251285: Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
Official title: Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prophylactic Nipple Sparing Mastectomy (NSM)
Keywords: robot
robotic
Nipple Sparing Mastectomy
NSM
da Vinci
surgery
mastectomy
prophylactic NSM
robot-assisted
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women eligible for prophylactic robotic-assisted Nipple-Sparing Mastectomy (unilateral or bilateral) according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System

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/X Surgical System as part of a PMCF Plan.

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of intraoperative R-NSM procedure and device-related complications
timeFrame: Assessed during surgery to 42 days after surgery
measure: Number of overall post-operative complications at 6 weeks
timeFrame: 6 weeks after the surgery
measure: Number of overall post-operative complications at 3 months
timeFrame: 3 months after the surgery
measure: Number of overall post-operative complications at 1 year
timeFrame: 1 year after the surgery
measure: 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
measure: Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
timeFrame: 6 weeks after surgery
measure: Number of conversions to open surgery
timeFrame: Assessed during surgery
measure: OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
timeFrame: Assessed during surgery to 6 weeks after surgery
measure: Number of transfusion and transfused units
timeFrame: Assessed during surgery to 6 weeks after surgery
measure: Hospital Length of Stay (LOS)
timeFrame: Assessed during the 6 weeks after surgery
measure: Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
timeFrame: at 6 weeks or upon surgeon's practice
measure: Number of readmissions associated with NSM surgery at 6 weeks
timeFrame: 6 weeks after surgery
measure: Number of readmissions associated with NSM surgery at 3 months
timeFrame: 3 months after surgery
measure: Number of reoperations associated with NSM surgery at 6 weeks
timeFrame: 6 weeks after surgery
measure: Number of reoperations associated with NSM surgery at 3 months
timeFrame: 3 months after surgery
measure: Result of BREAST-QTM (Quality of life) at 3 months
timeFrame: 3 months after surgery
measure: Result of BREAST-QTM (Quality of life) at 1 year
timeFrame: 1 year after surgery
measure: Result of NAC questionnaire (Quality of life) at 3 months
timeFrame: 3 months after surgery
measure: Result of NAC questionnaire (Quality of life) at 1 year
timeFrame: 1 year after surgery
measure: Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Antonio Toesca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gustave Roussy Cancer Campus
name: Benjamin Sarfati, MD
role: PRINCIPAL_INVESTIGATOR
References: