MedDataX Logo

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

NCT ID: NCT05251285

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prophylactic Nipple Sparing Mastectomy (NSM)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic Nipple-Sparing Mastectomy

Nipple-Sparing Mastectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nipple-Sparing Mastectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antonio Toesca, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Europeo di Oncologia

Benjamin Sarfati, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy Cancer Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gustave Roussy Cancer Campus

Villejuif, , France

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PN #1082409C

Identifier Type: -

Identifier Source: org_study_id