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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05500118
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
2. Female with age in 18-55 years old;
3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
4. No contraindications for sedation and analgesia;
5. Patients and their families agree to join this study, and can follow up on time.
Exclusion Criteria:
1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
4. The maximum diameter of leiomyoma is greater than or equal to 5cm;
5. Suspected malignant tumor, such as sarcoma;
6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs;
7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05500118
Study Brief:
Protocol Section:
NCT05500118