NCT06823414 Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
| NCT ID | NCT06823414 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alejandra García-Novoa |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | OBSERVATIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 126 participants in total. It began in 2025-02-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
Eligibility Criteria
Inclusion Criteria: * Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included. Exclusion Criteria: * Sarcomas of the breast. * Benign breast tumors. * Prepectoral reconstruction with expansion. * Impossibility to preserve the skin. * Need for reduction pattern * Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.). * Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations. * Refusal of the patient to participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06823414 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06823414 currently recruiting?
Yes, NCT06823414 is actively recruiting participants. Contact the research team at maria.alejandra.garcia.novoa@sergas.es for enrollment information.
Where is the NCT06823414 trial being conducted?
This trial is being conducted at A Coruña, Spain.
Who is sponsoring the NCT06823414 clinical trial?
NCT06823414 is sponsored by Alejandra García-Novoa. The trial plans to enroll 126 participants.
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