Prophylactic Nipple Sparing Mastectomy (NSM)PREVENTNCT05251285
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
An observational study of Prophylactic Nipple Sparing Mastectomy (NSM), run by Intuitive Surgical at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prophylactic Nipple Sparing Mastectomy (NSM)
- What is being tested?
- Nipple-Sparing Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Jan 2022to 18 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Being tested
- Nipple-Sparing Mastectomy
- Keywords
- robot, robotic, Nipple Sparing Mastectomy, NSM, da Vinci, surgery, mastectomy, prophylactic NSM, robot-assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple-Sparing MastectomyProcedure or surgery
Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Nipple-Sparing Mastectomy | Not described Receives: Procedure: Nipple-Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intraoperative R-NSM procedure and device-related complications
Measured: Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks
Measured: 6 weeks after the surgery
Number of overall post-operative complications at 3 months
Measured: 3 months after the surgery
Number of overall post-operative complications at 1 year
Measured: 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
Measured: 6 weeks after surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
Measured: 6 weeks after surgery
Number of conversions to open surgery
Measured: Assessed during surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
Measured: Assessed during surgery to 6 weeks after surgery
Number of transfusion and transfused units
Measured: Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)
Measured: Assessed during the 6 weeks after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
Measured: at 6 weeks or upon surgeon's practice
Number of readmissions associated with NSM surgery at 6 weeks
Measured: 6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months
Measured: 3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks
Measured: 6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months
Measured: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months
Measured: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
Measured: 1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months
Measured: 3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year
Measured: 1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start18 Jan 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Why it stopped: Low enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylactic Nipple Sparing Mastectomy (NSM)Studies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Toesca, MD, Principal investigator, Istituto Europeo di OncologiaBenjamin Sarfati, MD, Principal investigator, Gustave Roussy Cancer Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251285
- Sponsor's protocol ID
- PN #1082409C
- Acronym
- PREVENT
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05251285
- Acronym / sponsor ID
- PREVENT / PN #1082409C
- Keywords
- robot, robotic, Nipple Sparing Mastectomy, NSM, da Vinci, surgery, mastectomy, prophylactic NSM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrolment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Nipple-Sparing Mastectomy | – | Procedure: Nipple-Sparing Mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nipple-Sparing MastectomyNipple-Sparing Mastectomy using da Vinci X/Xi Surgical System | Procedure or surgery | Prophylactic Nipple-Sparing Mastectomy |
Primary outcome
Number of intraoperative R-NSM procedure and device-related complications
Time frame: Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks
Time frame: 6 weeks after the surgery
Number of overall post-operative complications at 3 months
Time frame: 3 months after the surgery
Number of overall post-operative complications at 1 year
Time frame: 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
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
Time frame: 6 weeks after surgery
Number of conversions to open surgery
Time frame: 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
Number of transfusion and transfused units
Time frame: Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)
Time frame: 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
Number of readmissions associated with NSM surgery at 6 weeks
Time frame: 6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months
Time frame: 3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks
Time frame: 6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months
Time frame: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months
Time frame: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
Time frame: 1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months
Time frame: 3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year
Time frame: 1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
Time frame: 1 year after surgery
Results and safety
The study was stopped early (reason given: Low enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Prophylactic Nipple Sparing Mastectomy (NSM)
Active, not recruiting
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
Nipple Sparing Mastectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Toesca, MD principal investigator
Istituto Europeo di Oncologia
Benjamin Sarfati, MD principal investigator
Gustave Roussy Cancer Campus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prophylactic Nipple Sparing Mastectomy (NSM), run by Intuitive Surgical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intraoperative R-NSM procedure and device-related complications (time frame: Assessed during surgery to 42 days after surgery). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.