NCT04240262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

January 20, 2020

Last Update Submit

April 28, 2023

Conditions

Uterine Fibroid

Outcome Measures

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

    6 months post treatment

Secondary Outcomes (3)

  • Quality of Life score

    6 months post treatment

  • menstrual bleeding

    6 months post treatment

  • acceptability

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

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with symptoms from uterine fibroids

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helena Kopp Kallner

Täby, 18352, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39697096DERIVED

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant ob/gyn

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 27, 2020

Study Start

January 20, 2020

Primary Completion

December 30, 2023

Study Completion

July 31, 2024

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

SE(1)