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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT02736435
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18 to 50 years
* Weight \<140kg
* Pre or perimenopausal
* Uterine size \<24 weeks
* Cervical screen by Pap test: Normal, Low Grade Squamous Intraepithelial Lesion, or Atypical Squamous Cells of Undetermined Significance as per Cancer Care Ontario guidelines
* Transformed symptom severity score ≥40
* Willing to attend all study visits
* Willing to complete evaluation forms
* Willing and able to use reliable contraception;
MR-HIFU Criteria Trial Arm 1:
* Minimum of 50% of fibroid volume accessible for treatment
* Dominant fibroid ≤8 cm
* Uterine volume \<900 cc
* Total fibroid treatment volume \<250 cc
* No more than 5 fibroids planned for ablation
* Completely non-enhancing fibroids should not be treated
MR-HIFU Criteria Trial Arm 2:
* Minimum of 50% of fibroid volume accessible for treatment
* Dominant fibroid \>8 cm or uterine volume \>900 cc
* Total fibroid treatment volume \<250 cc
* No more than 5 fibroids planned for ablation
* Completely non-enhancing fibroids should not be treated
Exclusion Criteria:
* Other pelvic disease (endometriosis, ovarian tumor, acute pelvic disease, other mass)
* Significant systemic disease even if well controlled
* Positive pregnancy test
* Abnormal uterine bleeding (participant can be included if an endometrial biopsy confirms no hyperplasia or malignancy in the past 6 months)
* Extensive scarring along anterior abdominal wall (\>50% of area)
* Surgical clips or scar tissue in the path of the MR-HIFU beam
* MRI contraindicated according to standard operating procedure
* MRI contrast contraindicated (including renal insufficiency)
* Calcifications around or throughout uterine tissues
* Fibroids not quantifiable on MRI
* Highly perfused or brighter than myometrium in T2-weighted MRI fibroids (Type 3 fibroids).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02736435
Study Brief:
Protocol Section:
NCT02736435