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The test group will be administered 300-500 ㎛ range of Gelatin microsphere (Nexsphere™). A suspension in which a contrast medium and physiological saline are mixed will be administered until the embolization is sufficiently achieved.

The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.

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.

Gelatin microsphere (Nexsphere™)

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

Embosphere

Man Deuk Kim, MD, PhD

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.

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.

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

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

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

Fentanyl and analgesic usage volume within 24 hours after embolization

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.

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

Assessment of tumor necrosis degree in MR after embolization

Fluoroscopy and procedure time taken for embolization to achieved

Residual ovarian function before and after embolization

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere	NCT05086770	Uterine Myoma Uterine Fibroid	Gelatin microsp... Embosphere	20 Years - 59 Years	Next Biomedical Co., Ltd.
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere	NCT05086770	Uterine Myoma Uterine Fibroid	Gelatin microsp... Embosphere	20 Years - 59 Years	Next Biomedical Co., Ltd.

Spots Global Cancer Trial Database for gelatin microsphere (nexsphere™)