Microwave Ablation for Leiomyoma

Uterine Fibroid Clinical Trial

— MYOMIC2  

Official title:

Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240262
• Other study ID #: MYOMIC2
• Status: Recruiting
• Start date: January 20, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Locations

Country	Name	City	State
Sweden	Helena Kopp Kallner	Taby

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity of uterine fibroids	Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire. minumum 0, maximum 100 where higher scores indicate higher symptom severity	6 months post treatment
Secondary	Quality of Life score	Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire.minumum 0, maximum 100 where higher scores indicate higher quality of life	6 months post treatment
Secondary	menstrual bleeding	Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding.	6 months post treatment
Secondary	acceptability	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.	2 hours post treatment and 6 months post treatment (+/- 2 weeks)