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Not Yet Recruiting
NCT05720039
Robotic vs. Open NSM for Early Stage Breast Cancer
Conditions: Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset
Sex: Female
Ages: 21 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Intuitive Surgical
Summary
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Eligibility Criteria
Inclusion Criteria:Female age 21 or olderBMI < 30Candidate for an NSM procedure with immediate reconstructionDiagnosis of early stage brest cancerBreast ptosis ≤ Grade 2.Cup size ≤ C.Exclusion Criteria:Previous breast surgeryDiagnosis of metastatic breast cancerPrior radiation treatment to the chestCurrent smokersContraindication for general anesthesia or surgery.Known bleeding or clotting disorder.Pregnant or suspected to be pregnant, or actively breastfeeding
Source: ClinicalTrials.gov (NCT05720039). StuddyBuddy aggregates publicly available trial information.
