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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT07209020
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70 years old.
* Patients are diagnosed with a benign or malignant breast tumor, that tumor size of ≦ 5 cm and no distant metastasis assessed by the imaging (breast ultrasonography, mammography, or MRI) and pathologic examination within 12 weeks before screening. If a benign breast tumor is identified through imaging and subsequently removed via surgery performed after the subject's enrollment in the study, the pathology report from that surgery should be used instead of any previous report.
* Patients diagnosed with a breast tumor, or those with a history of radiation and chemotherapy, who are scheduled to undergo surgery such as partial mastectomy, breast-conserving surgery, sentinel lymph node dissection, and/or axillary lymph node dissection .
* Patients who understand and are able to comply with follow-up visits and treatment during the trial period.
* Patients who are willing and capable of providing written informed consent. Not a person subject to a sentence of guardianship or subject to judicial guardians.
Exclusion Criteria:
* Patients with breast cancer stage III or IV.
* Patients with inflammatory breast cancer.
* Patients with multicentric lesions or lesions with diffuse microcalcification.
* Patients with retro areolar breast carcinoma.
* Have a history of severe allergies or are allergic to collagen.
* Collagen vascular disease.
* History of serious postoperative complications.
* Infected wound.
* Patients who require emergency surgery.
* Patients with coagulation dysfunction, such as abnormal preoperative coagulation time (prothrombin time (PT)\>18 seconds or partial thromboplastin time (PTT) \>50 seconds)
* Patients with untreated or unstable diabetes, that the fasting blood sugar \>180 mg/dL or postprandial blood sugar \>200 mg/dL.
* Patients with untreated or unstable chronic diseases, such as hypertension, hyperlipidemia, cardiovascular disease, stroke.
* Patients with Body mass index (BMI) \> 30.
* Patients who are pregnant or breastfeeding women.
* Patients with drug abuse or addiction.
* Others who have been judged by the principal investigator as participating in this trial will endanger their physical and mental health.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07209020
Study Brief:
Protocol Section:
NCT07209020