Uterine FibroidMYOMIC2NCT04240262
Microwave Ablation for Leiomyoma
An observational study of Uterine Fibroid, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with symptoms from uterine fibroids
Who may be able to join
- premenopausal
- no future child wish
- acceptable risks for general anestesia or sedation
- willing to comply with protocol
Who cannot join
- current or future child wish
- bleeding disorder with increased risk of bleeding
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Helena Kopp Kallner
Täby, 18352
Helena K Kallner, MD, +46704402070, helena.kopp-kallner@ki.se
Helena Kopp Kallner, MD
About this study
Official title: 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.
- Conditions
- Uterine Fibroid
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post treatment
Secondary outcomes (3)
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
Measured: 6 months post treatment
menstrual bleeding
Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding.
Measured: 6 months post treatment
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.
Measured: 2 hours post treatment and 6 months post treatment (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Jan 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Kopp Kallner, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240262
- Sponsor's protocol ID
- MYOMIC2
- Acronym
- MYOMIC2
- Status last verified
- Apr 2023
- First submitted
- 20 Jan 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonsdottir G, Beermann M, Lanz E, Nikodell A, Cronsioe A, Hasselrot K, Kopp-Kallner H. Ultrasound guided microwave ablation treatment of uterine fibroids: Clinical response and patient acceptability. Acta Obstet Gynecol Scand. 2025 Feb;104(2):350-356. doi: 10.1111/aogs.15041. Epub 2024 Dec 19.
PubMed 39697096
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)
- ClinicalTrials.gov ID
- NCT04240262
- Acronym / sponsor ID
- MYOMIC2 / MYOMIC2
- Conditions
- Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with symptoms from uterine fibroids
Key inclusion criteria (4 listed)
- premenopausal
- no future child wish
- acceptable risks for general anestesia or sedation
- willing to comply with protocol
Key exclusion criteria (2 listed)
- current or future child wish
- bleeding disorder with increased risk of bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Quality of Life score
Time frame: 6 months post treatment
menstrual bleeding
Time frame: 6 months post treatment
acceptability
Time frame: 2 hours post treatment and 6 months post treatment (+/- 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 39697096Jonsdottir G, Beermann M, Lanz E, Nikodell A, Cronsioe A, Hasselrot K, Kopp-Kallner H. Ultrasound guided microwave ablation treatment of uterine fibroids: Clinical response and patient acceptability. Acta Obstet Gynecol Scand. 2025 Feb;104(2):350-356. doi: 10.1111/aogs.15041. Epub 2024 Dec 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity of uterine fibroids (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.