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NCT06995118: HUAXI-h-01
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
NA trial testing HUAXI hole 1 in Breast Cancer Early Stage Breast Cancer (Stage 1-3) in 337 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | Du Zhenggui |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 337 |
| Start date | 17 June 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 31 December 2031 |
| Sites | 20 locations across China |
Drugs / interventions tested
- HUAXI hole 1
Conditions studied
- Breast Cancer Early Stage Breast Cancer (Stage 1-3) — all drugs for Breast Cancer Early Stage Breast Cancer (Stage 1-3) →
Sponsor
Du Zhenggui
Who can join
Adults 18 to 70, female only, with Breast Cancer Early Stage Breast Cancer (Stage 1-3). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06995118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07206394 — Feasibility Trial of ScarWork for Post-breast Surgery Pain Syndrome. · NA · recruiting
- NCT06791018 — Cancer Exercise: Evaluation of a Mobile App in Breast Cancer Survivors · NA · active not recruiting
Other Du Zhenggui trials
Trials by the same sponsor.
- NCT07257003 — A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy · NA · not yet recruiting
- NCT07237828 — Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06995118 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Du Zhenggui
- Last refreshed: 2 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06995118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing