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

December 18, 2023 updated by: Intuitive Surgical
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of intraoperative R-NSM procedure and device-related complications
Time Frame: Assessed during surgery to 42 days after surgery
Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks
Time Frame: 6 weeks after the surgery
6 weeks after the surgery
Number of overall post-operative complications at 3 months
Time Frame: 3 months after the surgery
3 months after the surgery
Number of overall post-operative complications at 1 year
Time Frame: 1 year after the surgery
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
Time Frame: 6 weeks after surgery
6 weeks after surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
Time Frame: 6 weeks after surgery
6 weeks after surgery
Number of conversions to open surgery
Time Frame: Assessed during surgery
Assessed during surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
Time Frame: Assessed during surgery to 6 weeks after surgery
Assessed during surgery to 6 weeks after surgery
Number of transfusion and transfused units
Time Frame: Assessed during surgery to 6 weeks after surgery
Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)
Time Frame: Assessed during the 6 weeks after surgery
Assessed during the 6 weeks after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
Time Frame: 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
Time Frame: 6 weeks after surgery
6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months
Time Frame: 3 months after surgery
3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks
Time Frame: 6 weeks after surgery
6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months
Time Frame: 3 months after surgery
3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months
Time Frame: 3 months after surgery
3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
Time Frame: 1 year after surgery
1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months
Time Frame: 3 months after surgery
3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year
Time Frame: 1 year after surgery
1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
Time Frame: 1 year after surgery
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intuitive Surgical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Toesca, MD, Istituto Europeo di Oncologia
  • Principal Investigator: Benjamin Sarfati, MD, Gustave Roussy Cancer Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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