Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT07237828
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged 18-70 years (inclusive);
* Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;
* Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;
* Patients with a maximum tumor diameter≤5 cm (before/after neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;
* BMI \< 40 kg/m²;
* Implant volume \< 600 mL;
* Patients who are able and willing to sign the informed consent form.
Exclusion Criteria:
* History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);
* Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;
* Advanced tumor stage (M1);
* Breast cancer during pregnancy or lactation;
* Scars below the nipple level and a history of previous radiotherapy;
* Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;
* HbA1c \> 7.5%;
* Active smoking history (≥20 cigarettes per day);
* Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;
* Currently participating in other clinical studies that may affect participation in this trial.
* Refusal to sign the informed consent form.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07237828
Study Brief:
Protocol Section:
NCT07237828