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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.
Must not have
Uncontrolled diabetes mellitus.
Known bleeding or clotting disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annual through 5 year post-operatively
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My diabetes is not well-managed.
Select...
I have a bleeding or clotting disorder.
Select...
I have or had breast cancer in the same breast I want preventive surgery on.
Select...
I cannot have surgery or be put under general anesthesia.
Select...
I have had chemotherapy or radiation before.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
77 Previous Clinical Trials
50,416 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
~15 spots leftby Apr 2025
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