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Completed

NCT Number: NCT03420248

Comparison of Pain of Two Different Methods in Uterine Artery Embolization

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

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sesverance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Pain intensity by numerical rating scale

    Time frame: 0-24 h after UAE

    0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable

Secondary outcomes

  1. C-reactive protein

    Time frame: 24 h after UAE

    mg/L

  2. White blood cell count

    Time frame: 24 h after UAE

    /uL

  3. Neutrophil percentage

    Time frame: 24 h after UAE

  4. Neutrophil-to-lymphocyte ratio

    Time frame: 24 h after UAE

  5. Platelet-to-lymphocyte ratio

    Time frame: 24 h after UAE

  6. Mean platelet volume

    Time frame: 24 h after UAE

    fL(femtolitre)

  7. Sucessful rate at 3 month after UAE measured by MRI

    Time frame: 3 month after UAE

    Complete necrosis incidence

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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