NCT05720039

Robotic vs. Open NSM for Early Stage Breast Cancer

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Intuitive Surgical · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Robotic NSM	Robotic-assisted Nipple sparing mastectomy procedures
PROCEDURE	Open NSM	open nipple-sparing mastectomy procedures

Timeline

• Start date: 2023-05-08
• Primary completion: 2026-03-01
• Completion: 2031-03-01
• First posted: 2023-02-09
• Last updated: 2026-02-24

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study