BridgeMD
New treatment option for Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Official title The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
ClinicalTrials.gov ID: NCT06995118
What this study is testing
- What it's testing
- 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".
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma...
- For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging...
- Patients volunteered to provide informed consent.
You likely can't join if
- 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;
See the full 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 reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty...
- 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...
- Patients volunteered to provide informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Hohhot, Inner Mongolia, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Deyang, Sichuan, China
- Mianyang, Sichuan, China
- Chongqing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Anyang, Henan, China; Zhengzhou, Henan, China; Changsha, Hunan, China; Hohhot, Inner Mongolia, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.