NCT06995118 The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
| NCT ID | NCT06995118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Du Zhenggui |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | INTERVENTIONAL |
| Enrollment | 337 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 337 participants in total. It began in 2025-06-17 with a primary completion date of 2026-06-01.
⚠ 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
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Eligibility Criteria
Inclusion criteria: * Female patients aged 18-70 years (inclusive18 and 70 years); * Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted; * Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy; * For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively; * Patients volunteered to provide informed consent. Exclusion criteria: * History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy); * Breast cancer diagnosed during pregnancy or lactation; * Subnipple-plane scarring with radiotherapy; * Metastatic breast cancer (M1); * Severe comorbidities precluding general anesthesia or surgery; * BMI ≥40 kg/m²; * HbA1c \>7.5%; * Immunodeficiency; * Active smoking with ≥20 cigarettes per day * Patients with concurrent participation in conflicting clinical trials.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06995118 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, 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 NCT06995118 currently recruiting?
Yes, NCT06995118 is actively recruiting participants. Contact the research team at docduzg@163.com for enrollment information.
Where is the NCT06995118 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Anyang, China, Zhengzhou, China and 11 additional locations.
Who is sponsoring the NCT06995118 clinical trial?
NCT06995118 is sponsored by Du Zhenggui. The trial plans to enroll 337 participants.
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