Robotic vs. Open NSM for Early Stage Breast Cancer

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Detailed Description
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This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM. This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Official Title
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A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Conditions
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Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast

Intervention / Treatment
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* Device: Robotic NSM
* Procedure: Open NSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age 21 or older BMI < 30 Candidate for an NSM procedure with immediate reconstruction Diagnosis of early stage brest cancer Breast ptosis ≤ Grade 2. Cup size ≤ C. Exclusion Criteria: Previous breast surgery Diagnosis of metastatic breast cancer Prior radiation treatment to the chest Current smokers Contraindication for general anesthesia or surgery. Known bleeding or clotting disorder. Pregnant or suspected to be pregnant, or actively breastfeeding

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic NSM with da Vinci SP<br>Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures | Device: Robotic NSM<br>* Robotic-assisted Nipple sparing mastectomy procedures<br>* Other names: SP NSM;|
| Active Comparator: Open NSM<br>Subjects randomized to this arm will undergo conventional open NSM procedures | Procedure: Open NSM<br>* open nipple-sparing mastectomy procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery | Assessed during procedure | 
| Safety: Adverse event rates | Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM | Up to 42 days post-operatively | 
| Safety: positive surgical margin rates | Incidence of positive surgical margins compared to open NSM | Up to 42 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological Outcomes (for cancer recurrence) | Recurrence | Up to 5 years | 
| Oncological Outcomes (for disease-free survival) | Disease-free survival | Up to 5 years | 
| Oncological Outcomes (for overall survival) | Overall survival | Up to 5 years | 
| Patient-Report Outcomes (BREAST-Q) | BREAST-Q | Up to 5 years | 
| Patient-Report Outcomes (NAC Questionnaire) | NAC Questionnaire | Up to 5 years | 
| Patient-Report Outcomes (EQ-5D) | EQ-5D | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, USA, robot, SP System, Single-port