NCT06860217Not yet recruiting
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- Apr 2025
- Primary completion date
- Apr 2032
- Lead sponsor
- European Institute of Oncology
- Diseases
- Childhood cancers
- NCT number
- NCT06860217
What you commit to
- Study type: Interventional
- Planned participants: 24
- From Apr 2025 to the primary completion date, Apr 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thoracic radiation therapy for any reason
Other illness
- Inflammatory Breast Cancer
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
- Uncompensated Diabetes Mellitus
Other
- Pregnancy
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.