Evaluation of the clinical- & cost-effectiveness of UltraSOund-guided RadioFrequency Ablation of Leiomyomas via the Transvaginal route (ESONATA)
Recruiting
- Conditions
- intrauterine leiomyomas, intrauterine fibroids, heavy menstrual bleeding
- Registration Number
- NL-OMON24224
- Lead Sponsor
- Máxima Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
1.Have selected Sonata, tomic myomectomy, laparoscopic hysterectomy for the treatment of leiomyomas
2.Presence of at least one submucous myoma (type 2) or transmural fibroid (type 2-5)
3.= 25 years of age at the time of enrollment
4.American Society of Anesthesiologist class 1 or 2
Exclusion Criteria
1.Clotting disorders
2.Inability to understand Dutch or English
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to return to work in days
- Secondary Outcome Measures
Name Time Method terine fibroid symptom and health-related quality of life, Reintervention rate, Complications,Costs, Satisfaction and recommendation to friend