New small-incision technique for breast cancer surgery with implant reconstruction

Plain-English translation of NCT06995118 on ClinicalTrials.gov ↗ · Source last updated July 2025 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a new surgical technique called the 'HUAXI Hole 1' method, which helps surgeons remove breast tissue while keeping the nipple intact and immediately placing a breast implant. The technique uses a tiny 2-millimeter additional opening to make the surgery safer, faster, and less visible than traditional open surgery.

Standard breast cancer surgery often leaves large, visible scars that can affect how patients feel about their appearance and well-being. While smaller-incision endoscopic surgery exists, it can be difficult and time-consuming, especially in certain parts of the breast. This trial is testing whether the new HUAXI Hole 1 technique can make the surgery easier and safer while keeping the same cosmetic benefits.

Do you qualify?

You likely qualify if…

you are a woman between 18 and 70 years old
you have been diagnosed with early-stage breast cancer (or are eligible for preventive mastectomy) with a tumor 5 cm or smaller
you have no sign that cancer has spread to your skin, chest wall, or other parts of your body
you are able to undergo general anesthesia and surgery safely
you are willing to give informed consent to participate

You likely don't qualify if…

you have had open breast surgery in the past year
you were diagnosed with breast cancer during pregnancy or breastfeeding
you have metastatic (stage 4) breast cancer
you have severe health conditions that make surgery unsafe, a very high BMI (≥40), uncontrolled diabetes, or active heavy smoking
you have had radiation therapy to the breast area or have a weakened immune system

What participation looks like

You would be randomly assigned to either receive the new HUAXI Hole 1 technique or the standard endoscopic surgery without it. Your surgery would involve breast tissue removal while preserving your nipple, followed by immediate implant placement. The research team will monitor your recovery to track surgical outcomes, how well you heal, and your satisfaction with the cosmetic results.

AI-generated summary from trial data · Jun 27, 2026 · Not medical advice

Trial locations(20 sites)

China

Fujian Medical University Union Hospital, Fuzhou, Fujian

Guangzhou First People's Hospital, Guangzhou, Guangdong

Anyang City Tumor Hospital, Anyang, Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan

The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan