Microwave Ablation for Leiomyoma

Recruiting

• Conditions: Uterine Fibroid

• Registration Number: NCT04240262
• Lead Sponsor: Karolinska Institutet

Brief Summary

This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• premenopausal
• no future child wish
• acceptable risks for general anestesia or sedation
• willing to comply with protocol

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Exclusion Criteria

• current or future child wish
• bleeding disorder with increased risk of bleeding

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom severity of uterine fibroids	6 months post treatment	Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire. minumum 0, maximum 100 where higher scores indicate higher symptom severity

Secondary Outcome Measures

Name	Time	Method
Quality of Life score	6 months post treatment	Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire.minumum 0, maximum 100 where higher scores indicate higher quality of life
acceptability	2 hours post treatment and 6 months post treatment (+/- 2 weeks)	Answer to question: if you were to recommend the treatment to a friend on a scale from 1-7 where 7 is the highest rating- what would you say.
menstrual bleeding	6 months post treatment	Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding.

Trial Locations

Locations (1)

Helena Kopp Kallner; 🇸🇪 Taby, Sweden