Clinical trial · Interventional
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
NCT05720039CI-TRIAL-00103892SP NSMactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer, Early-Onset | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open NSM | Procedure | — | UNRESOLVED |
| Robotic NSM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic NSM with da Vinci SP
- description
- Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
- interventionNames
- Device: Robotic NSM
- type
- ACTIVE_COMPARATOR
- label
- Open NSM
- description
- Subjects randomized to this arm will undergo conventional open NSM procedures
- interventionNames
- Procedure: Open NSM
Primary outcomes (3)
- measure
- Conversion rate
- timeFrame
- Assessed during procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.