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

Uterine Fibroid Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086770
• Other study ID #: NEXTBIO-UIGB-UF01
• Status: Completed
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2023
• Source: Next Biomedical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid
• Uterine Myoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Next Biomedical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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