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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT02410018
Eligibility Criteria:
Inclusion Criteria:
* presence of one or more of the following symptoms: abnormal menstrual bleeding, prolonged menstrual period, pelvic pain, or bulk-related symptoms that are attributed to uterine fibroids (bulk-related symptoms include pelvic pressure, abdominal distension, abdominal bloating, constipation, backache, urinary frequency, urinary retention, ureteral dilation, and rectal pressure), and the intensity of uterine fibroid-related symptoms, which are sufficiently sever to warrant hysterectomy, and the patient's medical history, physical examination, and the results of imaging by ultrasound or MRI;
* are between the ages of 30 and 55 years, inclusive;
* have had a pelvic examination by a gynaecologist within the previous 6 months;
* have had a normal Pap smear within the last 12 months;
* have had an endometrial biopsy within the previous three to six months, as appropriate to patient history;
* are premenopausal with menstrual cycles lasting between 22 and 35 days. A follicle stimulating hormone (FSH) value obtained within three months prior to the procedure must be \< 40 IU/L;
* are scheduled for total abdominal hysterectomy;
* are willing and able to provide written, informed consent.
Exclusion Criteria:
* have been treated with gonadotropin-releasing hormone (GnRH) agonists within the previous 12 weeks;
* have a American Society of Anesthesiologists (ASA) score ≥ 3;
* have abnormally large ovarian arteries, as assessed by MRA and determined by the Investigator;
* have an undiagnosed pelvic mass outside the uterus;
* have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies including the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, permanent hearing aids, or permanent eye-liner;
* have pedunculated subserosal fibroids with an attachment to the uterus less than one third of the greatest diameter of the fibroid;
* who do not agree to use contraceptives from Visit 1 until undergoing total abdominal hysterectomy;
* have compromised hematopoietic function;
* have hepatic dysfunction defined as liver function tests 30% above the upper limit of normal;
* have an active gynecologic or systemic infection;
* have renal dysfunction as defined by a serum creatinine \> 1.5 mg/dL
* have a history of gynecologic malignancy;
* have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids;
* have received other investigational drugs or who have had experimental therapy within the past four weeks or are participating in any other concurrent experimental therapy;
* have a uterine volume \< 250 mL or approximately \> 24 weeks gestation;
* have known endometrial hyperplasia, adenomyosis, or pelvic inflammatory disease;
* have abnormal coagulation profiles;
* are allergic to bovine collagen;
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT02410018
Study Brief:
Protocol Section:
NCT02410018