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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT02954757
Eligibility Criteria:
Inclusion Criteria:
* Age \>40 years old, with no future childbearing plans
* Age \>30 years old, who has tubal sterilization
* Significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery.
* Clinical uterine size less than 20 weeks gestation
* Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast MRI, involving only anterior or posterior uterine wall and not both.
* No laparotomy scars.
* Women should be able to give consent.
Exclusion Criteria:
* Other pelvic or uncontrolled systemic diseases
* Confirmed or suspected pregnancy
* Patients who are unable to communicate with researchers during the treatment
* Patients who are contraindicated for MRI examination
* Patients with thick abdominal wall (\>5 cm, as measured by MRI)
* Presence or history of acute pelvic inflammatory disease or any pelvic malignancy
* History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
* Presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT02954757
Study Brief:
Protocol Section:
NCT02954757