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Robotic Surgery

Robotic-Assisted Surgery for Breast Cancer Prevention

N/A
Recruiting
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
Breast ptosis ≤ Grade 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annual through 5 year post-operatively
Awards & highlights

Study Summary

This trial looks at whether a certain type of surgery is safe and effective for preventing breast cancer.

Who is the study for?
This trial is for women aged 18-80 at increased risk for breast cancer or with cancer in one breast, seeking preventive nipple-sparing mastectomy (NSM) on the other side. They should have a BMI ≤ 29, cup size ≤ C, and no more than Grade 2 breast ptosis. Candidates must not have had previous surgery on the target breast (except certain biopsies), uncontrolled diabetes, skin conditions affecting the breast, history of carcinoma in that breast, significant medical issues making anesthesia risky, bleeding/clotting disorders; they shouldn't be pregnant/lactating or recent smokers.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of using the da Vinci Xi Surgical System—a robotic-assisted device—for prophylactic NSM procedures to preventively remove breasts while sparing nipples among high-risk patients without active cancer in that specific breast.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with surgical procedures may include infection at incision sites, pain or discomfort post-surgery, potential complications from anesthesia use such as nausea or breathing difficulties and possible scarring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at high risk for breast cancer and considering preventive surgery, or I have cancer in one breast and want preventive surgery on the other.
Select...
My breast sagging is mild to moderate.
Select...
I don't have hidden cancer on the side I want preventive surgery, as confirmed by exams and imaging.
Select...
I am a woman aged between 18 and 80.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annual through 5 year post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and annual through 5 year post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness: No conversions to open NSM
Primary Safety: Incidence of adverse events
Other outcome measures
Incidence of breast cancer
Long-term safety: incidence of adverse events
Patient reported outcomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nipple Sparing MastectomyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
49,114 Total Patients Enrolled
2 Trials studying Nipple Sparing Mastectomy
105 Patients Enrolled for Nipple Sparing Mastectomy

Media Library

da Vinci Xi Surgical System (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT03892980 — N/A
Nipple Sparing Mastectomy Research Study Groups: Nipple Sparing Mastectomy
Nipple Sparing Mastectomy Clinical Trial 2023: da Vinci Xi Surgical System Highlights & Side Effects. Trial Name: NCT03892980 — N/A
da Vinci Xi Surgical System (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03892980 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of a younger age demographic eligible for inclusion in this research project?

"This clinical trial is open to individuals above the age of majority and below 80 years old."

Answered by AI

How many individuals have volunteered to be participants in this trial?

"To facilitate the trial, 145 individuals that meet all criteria need to be recruited. Intuitive Surgical is overseeing the project and will be managing sites such as MD Anderson Cancer Center (Texas) and Northwell Health (New york)."

Answered by AI

Are there still open slots available for enrollees in this research project?

"According to clinicaltrials.gov, this trial is still in the process of seeking participants. It was advertised on March 26th 2021 and recently updated on May 23rd 2022."

Answered by AI

What criteria must patients meet in order to be considered for enrollment into this clinical trial?

"This clinical trial is looking to recruit 145 participants, who must have had a nipple sparing mastectomy and be between 18 - 80 years old."

Answered by AI

Are there multiple sites hosting the research in America?

"The trial is being run in various medical centres such as MD Anderson Cancer Center (Houston), Northwell Health (New Hyde Park) and NorthShore University Health System (Evanston). Additionally, there are 6 other sites taking part."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy
2021. "Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03892980.
All > Surgery > Breast
~36 spots leftby Apr 2025
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