Robotic vs. Open NSM for Early Stage Breast Cancer
21 Years and older, Female
ISI dV SP - NSM-01 (primary)
NCI-2023-03998
Summary
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System
compared to Open NSM in Nipple Sparing Mastectomy procedures.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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