Comparing microwave and embolization treatments for adenomyosis
Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/transvaginal Microwave Ablation, Evaluated by Validated Questionnaires
This study is testing whether microwave treatment or embolization works better to relieve symptoms for women with adenomyosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04209127 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two minimally invasive treatments for adenomyosis: uterine artery embolization (UAE) and ultrasound-guided microwave ablation. It is a single-blinded randomized controlled trial that measures symptom improvement through validated questionnaires. The goal is to determine which treatment offers better outcomes for women suffering from this condition. The study aims to provide insights into alternative therapies that preserve the uterus and avoid the complications associated with hysterectomy.
Who should consider this trial
Good fit: Ideal candidates are healthy premenopausal women aged 30-55 with symptomatic adenomyosis diagnosed by transvaginal ultrasound.
Not a fit: Patients with a body mass index over 35, those on anticoagulants, or with contraindications for UAE or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with effective, less invasive treatment options for adenomyosis, reducing the need for hysterectomy.
How similar studies have performed: Previous studies have shown promising results with minimally invasive treatments for adenomyosis, but the microwave ablation approach is relatively novel and less tested in clinical settings outside of China.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women aged 30-55 with symptomatic adenomyosis * Premenopausal * Adenomyosis diagnosted by TVUS * Willing to comply with protocol Exclusion Criteria: * Body Mass Index \>35 * Treatment with anticoagulant/bleeding disorder * Contraindication for UAE or general anesthesia
Where this trial is running
Stockholm
- Danderyd Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Helena Kopp Kallner, MD PhD — Karolinska Institutet
- Study coordinator: Klara Hasselrot, MD PhD
- Email: klara.hasselrot@sll.se
- Phone: +46812358927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.