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Robotic vs. Open NSM for Early Stage Breast Cancer

NCT05720039 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-02-24

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Robotic NSM

Robotic-assisted Nipple sparing mastectomy procedures

PROCEDURE

Open NSM

open nipple-sparing mastectomy procedures

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Madhu Gorrepati · Intuitive

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2026-03-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720039 on ClinicalTrials.gov