The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction

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.

Trial Details

NCT ID
NCT06995118
Phase
NA
Sponsor
Du Zhenggui
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • HUAXI hole 1
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Anyang, Henan, China|36.096,114.38278
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Changsha, Hunan, China|28.19874,112.97087

Key Eligibility 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 reconstruct…
  • Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, i…
  • For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging…

For full eligibility, visit ClinicalTrials.gov.

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