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

Primary Purpose

Symptomatic Uterine Fibroids

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
uterine artery embolization using spherical gelfoam
uterine artery embolization using tri-acryl gelatin microsphere
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Uterine Fibroids focused on measuring Fibroid, Embolization, Pain, Inflammation

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spherical gelfoam

Microsphere

Arm Description

Patients who receive uterine artery embolization for symptomatic fibroids

Patients who receive uterine artery embolization for symptomatic fibroids

Outcomes

Primary Outcome Measures

Pain score (VAS score)
Maximum pain score measured during 24 hours after embolization

Secondary Outcome Measures

C-reactive protein (mg/L)
inflammatory markers
Tumor necrosis rate after embolization
technical success indicator
Symptom severity questionnaire
clinical success indicator
White blood cell count (/µL)
inflammatory markers
Neutrophil percentage (%)
inflammatory markers
Cumulative fentanyl dose (µg)
Total amount of IV fentanyl administered
Use of rescue analgesics (%)
Necessity of additional rescue analgesics
Lymphocyte percentage (%)
Inflammatory marker

Full Information

First Posted
June 23, 2021
Last Updated
July 11, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04960293
Brief Title
Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Uterine Fibroids
Keywords
Fibroid, Embolization, Pain, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spherical gelfoam
Arm Type
Experimental
Arm Description
Patients who receive uterine artery embolization for symptomatic fibroids
Arm Title
Microsphere
Arm Type
Active Comparator
Arm Description
Patients who receive uterine artery embolization for symptomatic fibroids
Intervention Type
Procedure
Intervention Name(s)
uterine artery embolization using spherical gelfoam
Intervention Description
Uterine artery embolization is performed using spherical gelfoam. All other processes are same.
Intervention Type
Procedure
Intervention Name(s)
uterine artery embolization using tri-acryl gelatin microsphere
Intervention Description
Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.
Primary Outcome Measure Information:
Title
Pain score (VAS score)
Description
Maximum pain score measured during 24 hours after embolization
Time Frame
up to 24 hours after embolization
Secondary Outcome Measure Information:
Title
C-reactive protein (mg/L)
Description
inflammatory markers
Time Frame
the day before and 24 hours after embolization
Title
Tumor necrosis rate after embolization
Description
technical success indicator
Time Frame
1 day and 3 months after embolization
Title
Symptom severity questionnaire
Description
clinical success indicator
Time Frame
before and 3 months after embolization
Title
White blood cell count (/µL)
Description
inflammatory markers
Time Frame
the day before and 24 hours after embolization
Title
Neutrophil percentage (%)
Description
inflammatory markers
Time Frame
the day before and 24 hours after embolization
Title
Cumulative fentanyl dose (µg)
Description
Total amount of IV fentanyl administered
Time Frame
within 24 hours after embolization
Title
Use of rescue analgesics (%)
Description
Necessity of additional rescue analgesics
Time Frame
within 24 hours after embolization
Title
Lymphocyte percentage (%)
Description
Inflammatory marker
Time Frame
the day before and 24 hours after embolization

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Women with symptomatic fibroids (age: 20 - 60 years old) Exclusion Criteria: Bradycardia (<45 bpm) Conduction abnormalities Liver failure renal failure Uncontrolled hypertension High grade obesity (BMI ≥ 30 kg/m2) Drug allergy Illiteracy Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Man-Deuk Kim
Phone
82-10-8625-2197
Email
mdkim@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Man-Deuk Kim
Organizational Affiliation
Department of Radiology, Severance hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man-Deuk Kim
Phone
82-10-8625-2197
Email
mdkim@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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