Clinical trial · Interventional
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
NCT06860217CI-TRIAL-00086791not yet 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)
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Mutation | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Nipple-Sparing Mastectomy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic Nipple-Sparing Mastectomy
- description
- Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction
- interventionNames
- Other: Robotic Nipple-Sparing Mastectomy
Primary outcomes (7)
- measure
- Surgery time
- timeFrame
- 1 month
- description
- Evaluation of average length of robotic procedure
- measure
- Post operative complications
- timeFrame
- 1 month
- description
- Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers * Any age * Negative preoperative assessment of nipple-areola complex * Absence of skin involvement * Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section * Breast volume ≤ Bra IV * No hard smoking (defined as \<=20 cigarettes/day) * Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale) * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up Exclusion Criteria: * Previous thoracic radiation therapy for any reason * Inflammatory Breast Cancer * Pregnancy * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study. * Uncompensated Diabetes Mellitus
References
Publications (0)
Data not yet available
No reference posted for this study.