RecruitingNCT06823414

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results


Sponsor

Alejandra García-Novoa

Enrollment

126 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques for removing breast tissue in people with breast cancer or high cancer risk: the traditional open approach versus a newer minimally invasive approach using an endoscope or robotic tools, both while preserving the nipple. **You may be eligible if...** - You are 18 or older - You have been diagnosed with breast cancer or have a high risk of developing it (e.g., BRCA gene mutation) - Your doctor recommends a nipple-sparing mastectomy - Your tumor (if present) is not directly under the nipple - You are in good enough health to undergo surgery **You may NOT be eligible if...** - Your cancer has spread beyond the breast (metastatic) - You have had previous radiation to the chest - You have inflammatory breast cancer - You are pregnant - You have a medical condition that makes surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVideo assisted mastectomy

Nipple Skin sparing mastectomy assisted by endoscopic or robotic


Locations(1)

Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4

A Coruña, Galicia, Spain

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NCT06823414


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