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Status unknownNCT04240262MYOMIC2Updated May 1, 2023

Microwave Ablation for Leiomyoma

An observational study in Uterine Fibroid, sponsored by Karolinska Institutet. Status unknown at 1 site in Sweden. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by Karolinska Institutet · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
25 Years and older
Sex
Female
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Study 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.

02

Conditions studied

  • Uterine Fibroid

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03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 119 observational studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with symptoms from uterine fibroids

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months post treatment

Secondary outcomes

  1. 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

    Time frame: 6 months post treatment

  2. menstrual bleeding

    Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding.

    Time frame: 6 months post treatment

  3. 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.

    Time frame: 2 hours post treatment and 6 months post treatment (+/- 2 weeks)

07

Study locations

1 of 1 sites recruiting
  • Helena Kopp Kallner
    Taby, 18352, Sweden
    • Helena K Kallner, MD · Contact · helena.kopp-kallner@ki.se · +46704402070
    • Helena Kopp Kallner, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04240262
Lead sponsor
Karolinska Institutet
Responsible party
Helena Kopp Kallner (Senior consultant ob/gyn, Karolinska Institutet) — Principal investigator
First posted
Jan 27, 2020
Start date
Jan 20, 2020
Primary completion
Dec 30, 2023 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
May 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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