RecruitingNot ApplicableNCT04209127

Comparing Efficacy of Microwave Vs Embolization Treatment 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


Sponsor

Karolinska Institutet

Enrollment

70 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 30 YearsMax Age: 55 Years

Inclusion Criteria4

  • Healthy women aged 30-55 with symptomatic adenomyosis
  • Premenopausal
  • Adenomyosis diagnosted by TVUS
  • Willing to comply with protocol

Exclusion Criteria3

  • Body Mass Index >35
  • Treatment with anticoagulant/bleeding disorder
  • Contraindication for UAE or general anesthesia

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Interventions

PROCEDUREMicrowave treatment via needle antenna

Microwave treatment via needle antenna, (Emprint Covidien microwave ablation system) either percutaneous or vaginally administrated

PROCEDUREEmbolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream)

Embolization via percutaneous catheter


Locations(1)

Danderyd Hospital

Stockholm, Sweden

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NCT04209127


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