Clinical trial · Observational
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
NCT04866992CI-TRIAL-00056090SPrNSMcompletedClinicalTrials.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 prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
Conditions
Conditions (12)
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 | — |
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Feasibility of completion of SPrNSM through axillary incision
- timeFrame
- Up to 1 year
- description
- Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision
- measure
- Complication rate of patients requiring re-operation
- timeFrame
- Up to 1 year
- description
- Number of patients with bleeding requiring a second surgery after SPrNSM
- measure
- Complication rate of patients with infection requiring explantation of tissue expander
- timeFrame
- Up to 1 year
- description
- Number of patients with infection after surgery requiring explantation of tissue expander
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Subjects age \>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW Exclusion Criteria: 1. Subjects who are \<18 years of age 2. Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
References
Publications (0)
Data not yet available
No reference posted for this study.