An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device (D-UAO) as Treatment for the Reduction of Fibroid-Associated Symptoms

Completed

• Conditions: Uterine Fibroids; 10013326; 10029903

• Registration Number: NL-OMON31776
• Lead Sponsor: ETHICON _ Johnson & Johnson MEdical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified