Clinical trial · Interventional
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
NCT05086770CI-TRIAL-00068018completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embosphere | Device | — | UNRESOLVED |
| Gelatin microsphere (Nexsphere™) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test group
- description
- 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.
- interventionNames
- Device: Gelatin microsphere (Nexsphere™)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.
- interventionNames
- Device: Embosphere
Primary outcomes (1)
- measure
- Pain intensity by numerical rating scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHan K, Kim SY, Kim MD, Kwon JH, Kim GM, Moon S, Park J, Kim HC, Won JY, Dhahi TMA, Choi J, Kim DK, Yang J, Shin HJ. Resorbable Microspheres versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization: A Randomized Controlled Trial. Radiology. 2024 Sep;312(3):e231525. doi: 10.1148/radiol.231525. PMID 39254451