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:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT03724903
Eligibility Criteria:
Inclusion Criteria:
* Female, age between 18 and 65 years old.
* Inform consent signed.
* Clinical diagnosis of non-lactating mastitis, defined as mastitis occurred more than 1 month after the cessation of lactation.
* Clinical and pathological diagnosis of idiopathic granulomatous mastitis.
* Never receive surgical treatments, or corticosteroids therapy after the cessation of lactation. Core needle biopsy is allowed.
* Good health, judged by clinicians, to receive ductal lavage.
* M score \>=2
Exclusion Criteria:
* Grade III inverted nipple(Plastic. Reconstruction. Surgery. 104: 389, 1999.)
* Lactational mastitis patients.
* Bilateral IGM patients.
* Clinically diagnosis of periductal mastitis.
* Pathological diagnosis of breast carcinoma.
* Pregnant women.
* Evidences suggest possible diagnosis of SLE(systemic lupus erythematosus), rheumatic disorders or other systematic auto-immune diseases.
* Evidences suggest possible diagnosis of tuberculosis.
* Evidences suggest possible diagnosis of fungus infection of the breast
* History of breast trauma.
* History of taking oral corticosteroids or anti-tuberculosis treatment.
* Imaging examinations indicates foreign objects retained in the breast
* Presence of sepsis or severe inflammation caused by IGM, for which surgery is likely required.
* Patients with inappropriate coagulation function, cardiac function, pulmonary function, liver and renal function, that clinicians judges as not suitable to participate in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03724903
Study Brief:
Protocol Section:
NCT03724903