Clinical trial · Interventional
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
NCT04537312CI-TRIAL-00099453active 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 is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Prognostic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IB Breast Cancer AJCC v8 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RNSM | Device | — | UNRESOLVED |
| Robot-assisted Nipple Sparing Mastectomy | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (RNSM, surveys)
- description
- RNMS Surveys
- interventionNames
- Procedure: Robot-assisted Nipple Sparing Mastectomy
- Other: Survey Administration
- Device: RNSM
Primary outcomes (7)
- measure
- Feasibility of removal of breast gland en bloc through RNSM
- timeFrame
- Up to 1 year
- description
- Measure number of patients who had breast removed en bloc through RNSM incision.
- measure
- Complication rate of patients with bleeding requiring re-operation
- timeFrame
- Up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Surgical candidates, per standard of care for: * Nipple sparing resection and reconstruction OR * Prophylactic mastectomy for risk reduction mastectomy OR * Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer * Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Pregnant or nursing women * Patients with: * Inflammatory breast cancer * Skin involvement with tumor * Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor * Grade 3 ptosis of nipple * Smokers with heavy current use of nicotine (defined as \> 20 cigarettes/day) * Patients that are high risk for anesthesia, as documented in medical record * Patients that do not have the ability to give informed consent * Prisoner status at surgical clinic visit * Bra cup size greater than C cup * Previous thoracic radiation history (for any reason)
References
Publications (1)
- DERIVEDPark KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173. PMID 34782341