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

Yonsei University

Status: Unknown

Conditions: Symptomatic Uterine Fibroids

Treatments: Procedure: uterine artery embolization using spherical gelfoam; Procedure: uterine artery embolization using tri-acryl gelatin microsphere

Study type: Interventional

Funder types: Other

Identifiers

NCT04960293

4-2021-0467

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Spherical gelfoam

Experimental group

Description:

Patients who receive uterine artery embolization for symptomatic fibroids

Treatment:

Procedure: uterine artery embolization using spherical gelfoam

Microsphere

Active Comparator group

Description:

Patients who receive uterine artery embolization for symptomatic fibroids

Treatment:

Procedure: uterine artery embolization using tri-acryl gelatin microsphere