Robotic vs. Open NSM for Early Stage Breast Cancer

Launched by INTUITIVE SURGICAL · Jan 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different surgical methods for treating early-stage breast cancer in women: a robotic technique using the da Vinci SP Surgical System and a traditional open surgery called Nipple Sparing Mastectomy (NSM). The goal is to see which method is safer and more effective for women undergoing this type of surgery, which allows for the removal of breast tissue while preserving the nipple and can be followed by immediate breast reconstruction.

To be eligible for this trial, participants need to be women aged 21 or older with a body mass index (BMI) of less than 30 who are suitable candidates for the NSM procedure. They should have early-stage breast cancer and certain breast characteristics, such as a cup size of C or smaller. Unfortunately, women who have had previous breast surgery, certain types of breast cancer, or other specific health issues won't be able to participate. If you join the study, you can expect to undergo one of the two surgical procedures and will be monitored for safety and effectiveness afterward. This trial is currently recruiting participants, so there's an opportunity to contribute to important research while receiving care for breast cancer.

Gender

FEMALE

Eligibility criteria

• 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