The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes

NCT ID: NCT05643339

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-31

Brief Summary

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The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.

Detailed Description

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Conditions

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Fibroid Uterus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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microvascular flow imaging

microvascular flow imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* one or more uterine fibroids
* diameter between 1,5 and 12 cm
* fibroid easily recognizable on ultrasound

Exclusion Criteria

* younger than 18 years
* pregnancy
* uterine or cervical malignancy
* adenomyosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Marjolein Spiering

Investigator Reseach Office Womens Child Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Huirne, Prof.

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Amsterdam UMC

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2017/494 and W20_274

Identifier Type: -

Identifier Source: org_study_id

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