uterus fibroids and adenomyosis
Conditions
Interventions
Embolization of myomas and/or adenomyosis (UAE) with the microcatheter 2.8F,
performed by experienced intervention radiologists.
Results are compared with retrospective status studies.
Sponsors
Sint Elisabeth Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - premenopausal woman, age > 30yrs and
Exclusion criteria
Exclusion criteria: - fibroid >= 5 cm - pregnancy - seeking future pregnancy - presence or suspicion of any gynaecologic malignancy - presence or suspicion of any pelvic inflammatory disease - pelvic congestion syndrome - already infarcted / calcified leiomyomata - bleeding disorder - renal function disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL scores and MRI (the difference in volume) are the two main study endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints are: - Number vials / ml particles used (+ size) - Number of protection coils used to avoid advert side branch non target embolization - Complications - Imaging post-procedure at 3 month follow up MRI: % necrosis (infarction 100% - 95- 100% or | — |
Countries
Netherlands
Outcome results
None listed