Uterine fibroids
Conditions
Interventions
A phase I, single-center clinical study was carried out in a hospital in southeastern Brazil, in which 20 women with uterine fibroids will be screened and trated with one session of microwave ablation
Sponsors
Fundação do ABC
Fundação do ABC
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; 18 of more years old; clinical diagnosis of uterine fibroids from type 2 to type 6, including classification of International Federation of Gynecology and Obstetrics 2-5; with a uterine volume above 50 mL; who report that they will not attempt pregnancy in the next 24 months at the beginning of the study; who have not undergone changes in their clinical conditions through conservative treatments or therapies; without signs of perimenopause; who have a safe transabdominal puncture course available; who report a desire to preserve the uterus; and who have voluntarily accepted microwave ablation treatment, by signing the informed consent form
Exclusion criteria
Exclusion criteria: Women who express a desire to stop participating in the study during the course of treatment; who become pregnant after the procedure; or who have clinically significant adenomyosis; women who have any malignancy in the genital organs,endometriosis requiring surgical treatment; other systemic diseases such as liver, kidney, or heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate differences in fibroid volume before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate differences in quality of life before and after treatment;To assess changes in participants' pain before and after treatment | — |
Countries
Brazil
Contacts
Public ContactMichel Zelaquett
Myoma Academy
Outcome results
None listed