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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04960293
Enrollment
60
Registered
2021-07-13
Start date
2021-07-31
Completion date
2023-05-31
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Uterine Fibroids

Keywords

Fibroid, Embolization, Pain, Inflammation

Brief 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

Detailed 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.

Interventions

PROCEDUREuterine artery embolization using spherical gelfoam

Uterine artery embolization is performed using spherical gelfoam. All other processes are same.

PROCEDUREuterine artery embolization using tri-acryl gelatin microsphere

Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score (VAS score)up to 24 hours after embolizationMaximum pain score measured during 24 hours after embolization

Secondary

MeasureTime frameDescription
Tumor necrosis rate after embolization1 day and 3 months after embolizationtechnical success indicator
Symptom severity questionnairebefore and 3 months after embolizationclinical success indicator
White blood cell count (/µL)the day before and 24 hours after embolizationinflammatory markers
C-reactive protein (mg/L)the day before and 24 hours after embolizationinflammatory markers
Cumulative fentanyl dose (µg)within 24 hours after embolizationTotal amount of IV fentanyl administered
Use of rescue analgesics (%)within 24 hours after embolizationNecessity of additional rescue analgesics
Lymphocyte percentage (%)the day before and 24 hours after embolizationInflammatory marker
Neutrophil percentage (%)the day before and 24 hours after embolizationinflammatory markers

Countries

South Korea

Contacts

Primary ContactMan-Deuk Kim
mdkim@yuhs.ac82-10-8625-2197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026