Comparison of Pain of Two Different Methods in Uterine Artery Embolization
Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids
1 other identifier
interventional
54
1 country
1
Brief Summary
The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
April 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2019
CompletedSeptember 19, 2019
September 1, 2019
10 months
January 16, 2018
September 17, 2019
Conditions
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 h after UAE
Secondary Outcomes (7)
C-reactive protein
24 h after UAE
White blood cell count
24 h after UAE
Neutrophil percentage
24 h after UAE
Neutrophil-to-lymphocyte ratio
24 h after UAE
Platelet-to-lymphocyte ratio
24 h after UAE
- +2 more secondary outcomes
Study Arms (2)
Non-spherical polyvinyl alcohol particle
EXPERIMENTALFor embolic material, non-spherical polyvinyl alcohol particle is used.
Tris-acryl gelatin microsphere
EXPERIMENTALFor embolic material, Tris-acryl gelatin microsphere is used.
Interventions
One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.
Eligibility Criteria
You may qualify if:
- Uterine artery embolization due to multiple fibroids
You may not qualify if:
- Severe liver or kidney dysfunction
- Drug allergy
- Bradycardia (\<45 bpm) or heart block
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sesverance Hospital, Yonsei University College of Medicine
Seoul, 03722, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
So Yeon Kim, MD, PhD
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
- PRINCIPAL INVESTIGATOR
Man Deuk Kim, MD, PhD
Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
January 16, 2018
First Posted
February 5, 2018
Study Start
April 19, 2018
Primary Completion
February 8, 2019
Study Completion
May 8, 2019
Last Updated
September 19, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share