Skip to main content
OpenTrials
Completed

NCT Number: NCT05086770

Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere

This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Myoma Connective Tissue Diseases Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases Uterine Fibroid

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 03722, South Korea

About this study

This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids.

The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization.

Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH).

This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.

Exclusion criteria

  • Bradycardia on electrocardiogram (< 45 bpm)
  • Ventricular conduction abnormalities
  • Liver failure
  • Kidney failure
  • Uncontrolled high blood pressure
  • Obesity (BMI ≥ 30 ㎏/㎡)
  • Patients who are allergic to drugs
  • Patients who cannot read consent forms such as illiterate or foreigners
  • Pregnant woman

Treatment and study plan

Gelatin microsphere (Nexsphere™)

Device

Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.

Embosphere

Device

Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.

Primary outcomes

  1. Pain intensity by numerical rating scale

    Time frame: 0-24 hours after embolization

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

Secondary outcomes

  1. Fentanyl and analgesic usage volume

    Time frame: 24 hours

    Fentanyl and analgesic usage volume within 24 hours after embolization

  2. Symptom severity score

    Time frame: 3 months

    Comparison of symptom severity score before and 3 months after embolization

    Symptom was scored on a scale of 0-10, with 0 being no symptoms and 10 being the baseline, or initial symptoms.

  3. Postoperative inflammation

    Time frame: 24 hours

    Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization

  4. Tumor necrosis degree

    Time frame: 3 months

    Assessment of tumor necrosis degree in MR after embolization

  5. Fluoroscopy and procedure time

    Time frame: procedure time

    Fluoroscopy and procedure time taken for embolization to achieved

  6. Serum Anti-Mullerian Hormone (AMH)

    Time frame: 3 months

    Residual ovarian function before and after embolization

Sponsors and collaborators

Lead sponsor

Next Biomedical Co., Ltd.

Industry

Registry information

Official study title

Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Jul 14, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.