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

Not Applicable

Completed

• Conditions: Uterine Myoma; Uterine Fibroid
• Interventions: Device: Gelatin microsphere (Nexsphere™); Device: Embosphere

• Registration Number: NCT05086770
• Lead Sponsor: Next Biomedical Co., Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2021-05-31
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-21
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Gelatin microsphere (Nexsphere™)	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.
Control group	Embosphere	The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.

Primary Outcome Measures

Name	Time	Method
Pain intensity by numerical rating scale	0-24 hours after embolization	0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of