Actively Recruiting
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Immediate Reconstruction With Prepectoral Implant for Breast Cancer: Prospective Study Evaluating Feasibility, Safety, Quality of Life, and Cosmetic Results
Led by Alejandra García-Novoa · Updated on 2025-02-12
126
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new technique for nipple skin sparing mastectomy using video-assisted methods like endoscopy or robotics. This study aims to compare this approach with traditional open mastectomy to see if it is at least as effective, focusing on how feasible the technique is, its safety in cancer treatment, and how it looks cosmetically. The study is observational and involves women who need mastectomy but do not require skin reduction or removal. The treatment being studied is a nipple skin sparing mastectomy performed with video assistance, either endoscopic or robotic. Participants undergo immediate breast reconstruction using a prepectoral implant. The study will observe the outcomes of this technique without randomization or a placebo group, focusing on women who have breast cancer or are at high risk for it. Participants will be followed to monitor several outcomes, including implant loss during the first year after surgery, local cancer relapse over five years, remaining glandular breast tissue within the first year, and overall survival at five years. Quality of life and cosmetic results will also be assessed using questionnaires. The study expects to track participants for up to five years to gather comprehensive data on safety, feasibility, and patient experience.
CONDITIONS
Brief Title
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who require a mastectomy and do not need skin reduction or resection
- Women with breast cancer or at high risk for breast cancer
You will not qualify if you...
- Sarcomas of the breast
- Benign breast tumors
- Prepectoral reconstruction with expansion
- Inability to preserve the skin
- Need for reduction pattern
- Inability to perform MRI during follow-up (due to obesity, claustrophobia, etc.)
- Cognitive issues preventing completion of the BREAST-Q17 questionnaire
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Hospital stay duration
Participants undergo video-assisted nipple skin sparing mastectomy with immediate prepectoral implant reconstruction and receive care immediately after surgery.
Duration - Up to 5 years
Participants are monitored after surgery for implant loss, local relapse, glandular residual tissue, and survival outcomes.
Regular visits during the first year and annual visits up to 5 years
Trial Site Locations
Total: 1 location
1
Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
A Coruña, Galicia, Spain, 15006
Actively Recruiting
Research Team
A
Alejandra García Novoa, PhD MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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