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Clinical Trials in Spain / NCT06823414
Recruiting Observational

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

NCT06823414 · tracked via the Priya Life Science Spain tracker
Sponsor
Alejandra García-Novoa
Phase
Observational
Started
2025-02-01
Last updated
2025-02-12

Condition(s) studied

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer Non-invasive Breast CancerHigh Risk Breast Carcinoma

Investigational drug(s) / intervention(s)

Video assisted mastectomy

Video assisted mastectomy: Nipple Skin sparing mastectomy assisted by endoscopic or robotic

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Implant Loss — First year after surgery
    Safety of the reconstruction technique, calculated by the number of implants lost

Trial sites (1)

FacilityCityRegionStatus
Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4 A Coruña Galicia Recruiting

Other trials for the same condition

Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients Recruiting
A Phase I Dose-escalation Trial of Definitive Single Dose Stereotactic Body Radiotherapy in Low-risk Breast Cancer Patients: DESERT I Trial Enrolling by invitation
Use of Intraoperative Radiotherapy in Breast Cancer Enrolling by invitation
BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06823414 on ClinicalTrials.gov ↗ ← All trials in Spain