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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroid; Uterine Myoma
• Intervention / Treatment: Device: Gelatin microsphere (Nexsphere™); Device: Embosphere

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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.	Device: Gelatin microsphere (Nexsphere™); 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.
Active Comparator: Control group; The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.	Device: Embosphere; Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity by numerical rating scale	0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable	0-24 hours after embolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fentanyl and analgesic usage volume	Fentanyl and analgesic usage volume within 24 hours after embolization	24 hours
Symptom severity score	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 months
Postoperative inflammation	Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization	24 hours
Tumor necrosis degree	Assessment of tumor necrosis degree in MR after embolization	3 months
Fluoroscopy and procedure time	Fluoroscopy and procedure time taken for embolization to achieved	procedure time
Serum Anti-Mullerian Hormone (AMH)	Residual ovarian function before and after embolization	3 months

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Man Deuk Kim, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: NEXTBIO-UIGB-UF01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No