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

NCT05086770 | Completed

• 1 other identifier: NEXTBIO-UIGB-UF01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Myoma; Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fentanyl and analgesic usage volume

  24 hours

• Symptom severity score

  3 months

• Postoperative inflammation

  24 hours

• Tumor necrosis degree

  3 months

• Fluoroscopy and procedure time

  procedure time

Study Arms (2)

Test group

EXPERIMENTAL

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™)

Control group

ACTIVE COMPARATOR

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

Device: Embosphere

Interventions

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.

Test group

Embosphere DEVICE

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

Control group

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Myofibroma; Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue

Study Officials

• Man Deuk Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 21, 2021
• Study Start: May 31, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

KR (1)