What side effects are associated with this type of intervention?

Common treatments for breast disease, particularly those involving surgical interventions like the da Vinci SP Surgical System for Nipple Sparing Mastectomy (NSM), include mastectomy and radiotherapy. Known side effects of these treatments can include weakness and fatigue, insomnia, chemotherapy-induced peripheral neuropathy (CIPN), lymphedema, and drug-induced arthralgia. Additionally, patients may experience pain, reduced range of motion, and cosmetic concerns related to scarring and breast reconstruction.

What prior FDA approvals exist?

The FDA has approved several treatments for breast disease, including surgical interventions and systemic therapies. For surgical treatments, the da Vinci Surgical System is a notable FDA-approved robotic-assisted platform used for procedures like nipple-sparing mastectomies (NSM). This system allows for minimally invasive surgeries with precision and potentially quicker recovery times. Other FDA-approved treatments for breast cancer include systemic therapies such as hormone therapies (e.g., tamoxifen, anastrozole), chemotherapy agents (e.g., doxorubicin, paclitaxel), and targeted therapies (e.g., trastuzumab for HER2-positive breast cancer). These treatments are often used in combination to manage and treat various stages of breast cancer.

What other types of research exist?

Promising alternatives to the da Vinci SP Surgical System for breast disease patients include: 1) The Senhance Surgical System, which offers haptic feedback and eye-tracking camera control; 2) The Versius Surgical System, known for its modular and portable design; 3) Advanced laparoscopic techniques with enhanced imaging and precision tools; 4) Single-port laparoscopic systems that minimize incisions and improve cosmetic outcomes. These alternatives are gaining traction due to their innovative features and potential benefits in surgical outcomes.

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Robotic Surgery

Robotic vs. Open Mastectomy for Breast Cancer (SP NSM Trial)

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

Breast ptosis ≤ Grade 2

Diagnosis of early stage breast cancer

Must not have

Contraindication for general anesthesia or surgery

Previous breast surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the safety and effectiveness of a new robotic surgery tool, the da Vinci SP Surgical System, to traditional open surgery for patients undergoing breast surgery that spares the nipple. The robotic system aims to improve precision and recovery. The da Vinci SP Surgical System is one of the latest versions of robotic surgery systems, designed for minimally invasive procedures.

Who is the study for?

This trial is for women over 21 with a breast cup size of C or smaller, BMI under 30, diagnosed with early stage breast cancer and suitable for Nipple Sparing Mastectomy (NSM) with immediate reconstruction. It's not for those who've had previous breast surgery, are pregnant/breastfeeding, have bleeding/clotting disorders, prior chest radiation treatment, smoke currently or can't undergo general anesthesia.

What is being tested?

The study compares the safety and effectiveness of two types of mastectomy procedures: one using the da Vinci SP Surgical System (Robotic NSM) and the other traditional open surgery (Open NSM). The goal is to see which method might be better for patients undergoing nipple sparing mastectomies.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include pain at the surgical site, infection risk from incisions, potential complications from anesthesia and possible differences in recovery time between robotic versus open surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast sagging is mild to moderate.

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I have been diagnosed with early stage breast cancer.

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I am a woman aged 21 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have general anesthesia or surgery due to health risks.

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I have had breast surgery before.

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I have a known bleeding or clotting disorder.

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I have had radiation treatment to my chest before.

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My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conversion rate

Safety: Adverse event rates

Safety: positive surgical margin rates

Secondary study objectives

Oncological Outcomes (for cancer recurrence)

Oncological Outcomes (for disease-free survival)

Oncological Outcomes (for overall survival)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Robotic NSM with da Vinci SPExperimental Treatment1 Intervention

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Group II: Open NSMActive Control1 Intervention

Subjects randomized to this arm will undergo conventional open NSM procedures

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast disease, particularly breast cancer, include surgical options such as mastectomy and lumpectomy, often combined with radiation therapy, chemotherapy, and hormone therapy. Robotic-assisted surgery, like the da Vinci SP Surgical System, enhances precision in procedures such as nipple-sparing mastectomy (NSM) by providing better visualization and dexterity. This minimally invasive approach reduces recovery time and surgical complications. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, balancing efficacy with quality of life considerations.

Local Breast Cancer Recurrence after Mastectomy and Breast-Conserving Surgery for Paget's Disease: A Meta-Analysis.