Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids

NCT ID: NCT04960293

Last Updated: 2021-07-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-05-31

Brief Summary

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The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam 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 spherical gelfoam 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 the two embolic agents with symptomatic fibroids.

Conditions

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Symptomatic Uterine Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spherical gelfoam

Patients who receive uterine artery embolization for symptomatic fibroids

Group Type EXPERIMENTAL

uterine artery embolization using spherical gelfoam

Intervention Type PROCEDURE

Uterine artery embolization is performed using spherical gelfoam. All other processes are same.

Microsphere

Patients who receive uterine artery embolization for symptomatic fibroids

Group Type ACTIVE_COMPARATOR

uterine artery embolization using tri-acryl gelatin microsphere

Intervention Type PROCEDURE

Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

Interventions

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uterine artery embolization using spherical gelfoam

Uterine artery embolization is performed using spherical gelfoam. All other processes are same.

Intervention Type PROCEDURE

uterine artery embolization using tri-acryl gelatin microsphere

Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1\. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria

1. Bradycardia (\<45 bpm)
2. Conduction abnormalities
3. Liver failure
4. renal failure
5. Uncontrolled hypertension
6. High grade obesity (BMI ≥ 30 kg/m2)
7. Drug allergy
8. Illiteracy
9. Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Man-Deuk Kim

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Severance hospital

Locations

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Man-Deuk Kim

Role: CONTACT

82-10-8625-2197

Facility Contacts

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Man-Deuk Kim

Role: primary

82-10-8625-2197

Other Identifiers

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4-2021-0467

Identifier Type: -

Identifier Source: org_study_id

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