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

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.

Study Overview

• Status: Terminated
• Conditions: Prophylactic Nipple Sparing Mastectomy (NSM)
• Intervention / Treatment: Procedure: Nipple-Sparing Mastectomy

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94800
    • Gustave Roussy Cancer Campus
• Italy
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylactic Nipple-Sparing Mastectomy	Procedure: Nipple-Sparing Mastectomy; Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of intraoperative R-NSM procedure and device-related complications	Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks	6 weeks after the surgery
Number of overall post-operative complications at 3 months	3 months after the surgery
Number of overall post-operative complications at 1 year	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	6 weeks after surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery	6 weeks after surgery
Number of conversions to open surgery	Assessed during surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times	Assessed during surgery to 6 weeks after surgery
Number of transfusion and transfused units	Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)	Assessed during the 6 weeks after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice	at 6 weeks or upon surgeon's practice
Number of readmissions associated with NSM surgery at 6 weeks	6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months	3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks	6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months	3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months	3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year	1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months	3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year	1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice	1 year after surgery

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Antonio Toesca, MD, Istituto Europeo di Oncologia; Principal Investigator: Benjamin Sarfati, MD, Gustave Roussy Cancer Campus

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: surgery; robotic; robot; mastectomy; robot-assisted; da Vinci; NSM; prophylactic NSM; Nipple Sparing Mastectomy
• Other Study ID Numbers: PN #1082409C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No