Microwave Ablation for Leiomyoma (MYOMIC2)

April 28, 2023 updated by: Helena Kopp Kallner, Karolinska Institutet

Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Taby, Sweden, 18352
        • Recruiting
        • Helena Kopp Kallner
        • Principal Investigator:
          • Helena Kopp Kallner, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with symptoms from uterine fibroids

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life score
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 quality of life
6 months post treatment
menstrual bleeding
Time Frame: 6 months post treatment
Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding.
6 months post treatment
acceptability
Time Frame: 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.
2 hours post treatment and 6 months post treatment (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYOMIC2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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