NCT04240262
Recruiting
Not Applicable
Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)
ConditionsUterine Fibroid
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Fibroid
- Sponsor
- Karolinska Institutet
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Symptom severity of uterine fibroids
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Helena Kopp Kallner
Senior consultant ob/gyn
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •premenopausal
- •no future child wish
- •acceptable risks for general anestesia or sedation
- •willing to comply with protocol
Exclusion Criteria
- •current or future child wish
- •bleeding disorder with increased risk of bleeding
Outcomes
Primary Outcomes
Symptom severity of uterine fibroids
Time Frame: 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 Outcomes
- Quality of Life score(6 months post treatment)
- acceptability(2 hours post treatment and 6 months post treatment (+/- 2 weeks))
- menstrual bleeding(6 months post treatment)
Study Sites (1)
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