Evaluation of the clinical- & cost-effectiveness of UltraSOund-guided RadioFrequency Ablation of Leiomyomas via the Transvaginal route (ESONATA)

Is the removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation a clinical- and cost-effective alternative for laparoscopic hysterectomy and tomic myomectomy?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24224

Enrollment

Registered

2019-12-20

Start date

2019-12-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine leiomyomas, intrauterine fibroids, heavy menstrual bleeding

Interventions

Removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation (Sonata system)

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Clotting disorders 2. Inability to understand Dutch or English

Design outcomes

Primary

Measure	Time frame
Time to return to work in days	—

Secondary

Measure	Time frame
Uterine fibroid symptom and health-related quality of life, Reintervention rate, Complications,Costs, Satisfaction and recommendation to friend	—

Contacts

Public ContactMarlies Bongers

Máxima Medisch Centrum

m.bongers@mmc.nl040-8888384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)