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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT04345003
Eligibility Criteria:
Inclusion Criteria:
* Woman
* Aged more than 18 years
* Not postmenopausal
* Having one or two symptomatic fibroid with size \< 15cm.
* Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
* Normal cervicovaginal smear performed within 2 years prior to inclusion
* Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
* SSS score on UFS-Qol ≥ 10
* Signed informed consent prior to any study related procedure
* With a medical insurance
Exclusion Criteria:
* Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
* Presence or suspicious of pelvic malignant tumor
* Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl)
* Pregnant or lactating woman
* Small submucous myoma accessible for hysteroscopic treatment.
* Active pelvic infection
* Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04345003
Study Brief:
Protocol Section:
NCT04345003