Uterine Leiomyoma
Conditions
Keywords
Embolization, Uterine Leiomyoma, Embospheres, Microspheres
Brief summary
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
Interventions
DEVICEUterine Embolization
Uterine Embolization with PVA Microspheres
Sponsors
Scitech Produtos Medicos Ltda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm, open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* female patients from 18 to 50 years old; * symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural; * patient agrees with study procedures; * patient signs the informed consent form.
Exclusion criteria
* asymptomatic women; * isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma; * leiomyoma diameter higher than 10 cm; * leiomyoma above the umbilical scar; * endometrial neoplasia or hyperplasia or presence of any malignancy * pregnant or breast feeding women; * active vasculitis; * pelvic irradiation history; * uncontrolled coagulopathies; * renal insufficiency; * contrast allergy; * concomitant use of GnRH analogues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine Volume Reduction | 6 months | Uterine Volume Reduction measured by MRI |
| Fibroid Reduction | 6 months | Fibroid Reduction measured by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Improvement | 6 months | Quality of Life Improvement measured by UFS-QOL |
| Ovarian Function | 6 months | Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure |
Countries
Brazil
Outcome results
None listed