Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/transvaginal Microwave Ablation, Evaluated by Validated Questionnaires

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Single blinded randomized controlled study of symptom improvement after uterine artery embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation, evaluated by validated questionnaires. Adenomyosis is a benign condition causing pain and bleeding disorders in many women. Hysterectomy has historically been the golden standard for treatment as well as (postoperatively) diagnosis of the disease. In accordance with refined diagnostic tools such as ultrasound and/or MRI, minimally invasive treatments for adenomyosis are being explored. We plan to compare two minimally invasive techniques: embolization of the uterine artery (a commonly used procedure) and microwave ablation of adenomyotic tissue (previously only in clinical use in China).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 55
Healthy Volunteers: f
View:

• Healthy women aged 30-55 with symptomatic adenomyosis

• Premenopausal

• Adenomyosis diagnosted by TVUS

• Willing to comply with protocol

Locations
Other Locations
Sweden
Danderyd Hospital
RECRUITING
Stockholm
Contact Information
Primary
Klara Hasselrot, MD PhD
klara.hasselrot@sll.se
+46812358927
Time Frame
Start Date: 2020-09-16
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 70
Treatments
Experimental: Microwave treatment
Percutaneous or vaginal application of microwave antenna with microwave treatment for adenomyosis
Active_comparator: Control
Uterine artery embolization; percutaneous application of a catheter into the femoral artery or branches thereof
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov