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Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis

NCT04209127 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-20

No results posted yet for this study

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).

Conditions

  • Adenomyosis

Interventions

PROCEDURE

Microwave treatment via needle antenna

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

PROCEDURE

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

Embolization via percutaneous catheter

Sponsors & Collaborators

Principal Investigators

  • Helena Kopp Kallner, MD PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04209127 on ClinicalTrials.gov