NCT04960293

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

June 23, 2021

Last Update Submit

July 11, 2021

Conditions

Symptomatic Uterine Fibroids

Keywords

FibroidEmbolizationPainInflammation

Outcome Measures

Primary Outcomes (1)

  • Pain score (VAS score)

    Maximum pain score measured during 24 hours after embolization

    up to 24 hours after embolization

Secondary Outcomes (8)

  • C-reactive protein (mg/L)

    the day before and 24 hours after embolization

  • Tumor necrosis rate after embolization

    1 day and 3 months after embolization

  • Symptom severity questionnaire

    before and 3 months after embolization

  • White blood cell count (/µL)

    the day before and 24 hours after embolization

  • Neutrophil percentage (%)

    the day before and 24 hours after embolization

  • +3 more secondary outcomes

Study Arms (2)

Spherical gelfoam

EXPERIMENTAL

Patients who receive uterine artery embolization for symptomatic fibroids

Procedure: uterine artery embolization using spherical gelfoam

Microsphere

ACTIVE COMPARATOR

Patients who receive uterine artery embolization for symptomatic fibroids

Procedure: uterine artery embolization using tri-acryl gelatin microsphere

Interventions

uterine artery embolization using spherical gelfoamPROCEDURE

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

Spherical gelfoam
uterine artery embolization using tri-acryl gelatin microspherePROCEDURE

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

Microsphere

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Women with symptomatic fibroids (age: 20 - 60 years old)

You may not qualify if:

  • Bradycardia (\<45 bpm)
  • Conduction abnormalities
  • Liver failure
  • renal failure
  • Uncontrolled hypertension
  • High grade obesity (BMI ≥ 30 kg/m2)
  • Drug allergy
  • Illiteracy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

LeiomyomaPainInflammation

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Man-Deuk Kim

    Department of Radiology, Severance hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Man-Deuk Kim

CONTACT

82-10-8625-2197mdkim@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 13, 2021

Study Start

July 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

KR(1)