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

NCT05251285 | Terminated

• 1 other identifier: PN #1082409C
• Study Type: observational
• Target: 7
• Locations: 2 countries
• Sites: 2

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.

Conditions

Prophylactic Nipple Sparing Mastectomy (NSM)

Keywords

robot; robotic; Nipple Sparing Mastectomy; NSM; da Vinci; surgery; mastectomy; prophylactic NSM; robot-assisted

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (1)

Prophylactic Nipple-Sparing Mastectomy

Procedure: Nipple-Sparing Mastectomy

Interventions

Nipple-Sparing Mastectomy PROCEDURE

Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System

Prophylactic Nipple-Sparing Mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (2)

Gustave Roussy Cancer Campus

Villejuif, 94800, France

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

MeSH Terms

Interventions

Mastectomy, Subcutaneous

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Antonio Toesca, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

• Benjamin Sarfati, MD

  Gustave Roussy Cancer Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 22, 2022
• Study Start: January 18, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); FR (1)