Active — Not RecruitingNot Applicable

Robotic vs. Open NSM for Early Stage Breast Cancer

United States204 participantsStarted 2023-05-08

Plain-language summary

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

Who can participate

Age range21 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Conversion rate

Timeframe: Assessed during procedure

Safety: Adverse event rates

Timeframe: Up to 42 days post-operatively

Safety: positive surgical margin rates

Timeframe: Up to 42 days post-operatively

Trial details

NCT IDNCT05720039

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Breast Cancer Female trials