Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids

Symptomatic Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04960293
• Other study ID #: 4-2021-0467
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: May 2023

Study information

• Verified date: July 2021
• Source: Yonsei University
• Contact: Man-Deuk Kim
• Phone: 82-10-8625-2197
• Email: mdkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Description:

Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria:

1. Bradycardia (<45 bpm)

2. Conduction abnormalities

3. Liver failure

4. renal failure

5. Uncontrolled hypertension

6. High grade obesity (BMI = 30 kg/m2)

7. Drug allergy

8. Illiteracy

9. Pregnancy

Related Conditions & MeSH terms

• Leiomyoma
• Symptomatic Uterine Fibroids

Intervention

Procedure:
• uterine artery embolization using spherical gelfoam
Uterine artery embolization is performed using spherical gelfoam. All other processes are same.
• uterine artery embolization using tri-acryl gelatin microsphere
Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score (VAS score)	Maximum pain score measured during 24 hours after embolization	up to 24 hours after embolization
Secondary	C-reactive protein (mg/L)	inflammatory markers	the day before and 24 hours after embolization
Secondary	Tumor necrosis rate after embolization	technical success indicator	1 day and 3 months after embolization
Secondary	Symptom severity questionnaire	clinical success indicator	before and 3 months after embolization
Secondary	White blood cell count (/µL)	inflammatory markers	the day before and 24 hours after embolization
Secondary	Neutrophil percentage (%)	inflammatory markers	the day before and 24 hours after embolization
Secondary	Cumulative fentanyl dose (µg)	Total amount of IV fentanyl administered	within 24 hours after embolization
Secondary	Use of rescue analgesics (%)	Necessity of additional rescue analgesics	within 24 hours after embolization
Secondary	Lymphocyte percentage (%)	Inflammatory marker	the day before and 24 hours after embolization