Back to results

Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Primary Purpose

Leiomyoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

About this trial

This is an interventional prevention trial for Leiomyoma

Eligibility Criteria

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

Inclusion Criteria:

Uterine artery embolization due to multiple fibroids

Exclusion Criteria:

Severe liver or kidney dysfunction
Drug allergy
Bradycardia (<45 bpm) or heart block
Uncontrolled hypertension

Sites / Locations

Sesverance Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Non-spherical polyvinyl alcohol particle

Tris-acryl gelatin microsphere

Arm Description

For embolic material, non-spherical polyvinyl alcohol particle is used.

For embolic material, Tris-acryl gelatin microsphere is used.

Outcomes

Primary Outcome Measures

Pain intensity by numerical rating scale

0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable

Secondary Outcome Measures

C-reactive protein

mg/L

White blood cell count

/uL

Neutrophil percentage

Neutrophil-to-lymphocyte ratio

Platelet-to-lymphocyte ratio

Mean platelet volume

fL(femtolitre)

Sucessful rate at 3 month after UAE measured by MRI

Complete necrosis incidence

Full Information

NCT ID

NCT03420248

First Posted

January 16, 2018

Last Updated

September 17, 2019

Sponsor

Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03420248

Brief Title

Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Official Title

Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 19, 2018 (Actual)

Primary Completion Date

February 8, 2019 (Actual)

Study Completion Date

May 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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 non-spherical polyvinyl alcohol particle 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 non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-spherical polyvinyl alcohol particle

Arm Type

Experimental

Arm Description

For embolic material, non-spherical polyvinyl alcohol particle is used.

Arm Title

Tris-acryl gelatin microsphere

Arm Type

Experimental

Arm Description

For embolic material, Tris-acryl gelatin microsphere is used.

Intervention Type

Device

Intervention Name(s)

Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Intervention Description

One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.

Primary Outcome Measure Information:

Title

Pain intensity by numerical rating scale

Description

0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable

Time Frame

0-24 h after UAE

Secondary Outcome Measure Information:

Title

C-reactive protein

Description

mg/L

Time Frame

24 h after UAE

Title

White blood cell count

Description

/uL

Time Frame

24 h after UAE

Title

Neutrophil percentage

Time Frame

24 h after UAE

Title

Neutrophil-to-lymphocyte ratio

Time Frame

24 h after UAE

Title

Platelet-to-lymphocyte ratio

Time Frame

24 h after UAE

Title

Mean platelet volume

Description

fL(femtolitre)

Time Frame

24 h after UAE

Title

Sucessful rate at 3 month after UAE measured by MRI

Description

Complete necrosis incidence

Time Frame

3 month after UAE

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Uterine artery embolization due to multiple fibroids Exclusion Criteria: Severe liver or kidney dysfunction Drug allergy Bradycardia (<45 bpm) or heart block Uncontrolled hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

So Yeon Kim, MD, PhD

Organizational Affiliation

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Man Deuk Kim, MD, PhD

Organizational Affiliation

Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sesverance Hospital, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Pain of Two Different Methods in Uterine Artery Embolization

We'll reach out to this number within 24 hrs