Comparison of Pain of Two Different Methods in Uterine Artery Embolization

NCT ID: NCT03420248

Last Updated: 2019-09-19

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

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2019-05-08

Brief Summary

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The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Detailed Description

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Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The non-spherical polyvinyl alcohol particle and tri-acryl gelatin microsphere are two embolic materials used for UAE.Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Conditions

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Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non-spherical polyvinyl alcohol particle

For embolic material, non-spherical polyvinyl alcohol particle is used.

Group Type EXPERIMENTAL

Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Intervention Type DEVICE

One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.

Tris-acryl gelatin microsphere

For embolic material, Tris-acryl gelatin microsphere is used.

Group Type EXPERIMENTAL

Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Intervention Type DEVICE

One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.

Interventions

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Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Uterine artery embolization due to multiple fibroids

Exclusion Criteria

* Severe liver or kidney dysfunction
* Drug allergy
* Bradycardia (\<45 bpm) or heart block
* Uncontrolled hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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So Yeon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

Man Deuk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine

Locations

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Sesverance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2016-1108

Identifier Type: -

Identifier Source: org_study_id

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