Uterine Fibroids
Conditions
Interventions
Doppler Guided Uterine Artery Occlusion, Bilateral
Sponsors
ETHICON _ Johnson & Johnson MEdical Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.25 to 50 years of age;2.Subject has a negative pregnancy test prior to the procedure. At the time of enrolment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12-months of the study period (unless sterilized);3.Normal pap smear within 36 months of study procedure;4.Normal endometrial biopsy within 36 months of study procedure;5.Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement); 6.At least one intra-mural uterine fibroid of greater than or equal to 3cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound; 7.Subject agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the EC-approved informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnancy as confirmed by positive urine pregnancy test; 2.Menopausal as defined by elevated follicle-stimulating hormone (FSH) and oestradiol hormone levels as determined by the hospital local laboratory reference range criteria;3.Presence of an intra-uterine device (IUD);4.Presence of only sub-mucosal fibroids or any pedunculated fibroids as determined by MRI, ultrasound or hysteroscopy; 5.Severe hydronephrosis as determined on renal ultrasound pre-procedurally; 6.Clinical history of any thromboembolic disease;7.Blood Urine Nitrogen (BUN) greater than 7.2mmol/L* and/or serum creatinine greater than 106*mol/L* unresolved with change in diet or hydration; 8.History of gynecologic malignancy, atypical endometrial hyperplasia, or chronic pelvic inflammatory disease;9.Pelvic mass outside the uterus other than uterine fibroids;10.Any current acute or chronic systemic infection or localized pelvic infection, including a urinary tract infection;11.Use of GnRH agonist or mifepristone within 6-months prior to the start of the study procedure unless used immediately prior to the procedure. 12.Using anticoagulation therapy (except over the counter treatments (e.g. aspirin)), or have an underlying bleeding disorder; 13.Unsuitable for MRI examination (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices)14.Prior endometrial ablation, uterine artery embolisation, or uterine artery ligation;15.Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease); and 16.If applicable, Grade 1 (no flow visualized) on ureter flow assessment. *or above applicable local lab normal values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint will be the percentage of subjects with the following definition of individual success at 12-months: *Lack of surgical re-intervention. Surgical re-intervention is defined as hysterectomy, Uterine Artery Embolisation (UAE), laparoscopic uterine artery occlusion, endometrial ablation, myomectomy (open, laparoscopic, hysteroscopic), endometrial resection, or myolysis by any method (including but not limited to: cryomyolysis, cautery, ultrasound, or laser).The primary safety endpoint is the incidence of adverse device effects (defined as related to the device) that result in any of the following treatments or outcomes:*Ureteral stenting;*Intra- operative or post-treatment blood transfusion;*Unintended major surgical procedure related to treatment;*Device-related re-hospitalisation greater than 24 hours;*Interventional treatment within 6-weeks of the D-UAO procedure;*Outpatient treatment of significant new medical problems, related to treatment;*Deep vein thrombosis (DVT) or pulmonary embolism (PE);*Life- threatening cardiac or respiratory arrest or other life-threatening events;*Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| *SYMPTOM IMPROVEMENToPercentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores at 6, 12 and 24 months. Symptom severity response defined as a change of *11 in the transformed score and HRQL response defined as a change of +12 in the transformed score. oMean improvement in UFS-QOL Symptom Severity and HRQL transformed scores at 6, 12 and 24 months.oMean HRQL subscales at 6, 12 and 24 months.*REDUCTION IN BLEEDINGoPercentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score at 6 and 12 months.oMean change in PBLAC scores from baseline to 6 and 12 months. *PROCEDURAL SUCCESS oPercentage of subjects with decrease in fibroid load at 6 months based on independent MRI review.oPercentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months at 12-months. oPercentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied at 12-months. *HEALTH ECONOMICS oPain score at discharge or 24-hour post clamp removal, whichever is earlieroDays to normal activities (household, work and sexual intercourse)oEuro-QOL at 1, 3, 6 and 12 months expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS) oNights in hospital (Total and post procedure) | — |
Countries
Netherlands
Outcome results
None listed