Symptomatic Uterine FibroidsNCT04960293
Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids
A study testing uterine artery embolization using spherical gelfoam and uterine artery embolization using tri-acryl gelatin microsphere in people with Symptomatic Uterine Fibroids, run by Yonsei University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Symptomatic Uterine Fibroids
- What is being tested?
- uterine artery embolization using spherical gelfoam and uterine artery embolization using tri-acryl gelatin microsphere
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women with symptomatic fibroids (age: 20 - 60 years old)
Who cannot join
- Bradycardia (<45 bpm)
- Conduction abnormalities
- Liver failure
- renal failure
- Uncontrolled hypertension
- High grade obesity (BMI ≥ 30 kg/m2)
Show all 9Show fewer
- Drug allergy
- Illiteracy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
Man-Deuk Kim, 82-10-8625-2197, mdkim@yuhs.ac
About this study
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
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
Read the 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.
- Conditions
- Symptomatic Uterine Fibroids
- Being tested
- uterine artery embolization using spherical gelfoam, uterine artery embolization using tri-acryl gelatin microsphere
- Keywords
- Fibroid, Embolization, Pain, Inflammation
- Medical subject headings
- Leiomyoma, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery embolization using spherical gelfoamProcedure or surgery
Uterine artery embolization is performed using spherical gelfoam. All other processes are same.
uterine artery embolization using tri-acryl gelatin microsphereProcedure or surgery
Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.
| Study group | Role | What they receive |
|---|---|---|
| Spherical gelfoam | Experimental | Patients who receive uterine artery embolization for symptomatic fibroids Receives: Procedure: uterine artery embolization using spherical gelfoam |
| Microsphere | Active comparator | Patients who receive uterine artery embolization for symptomatic fibroids Receives: Procedure: uterine artery embolization using tri-acryl gelatin microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (VAS score)
Maximum pain score measured during 24 hours after embolization
Measured: up to 24 hours after embolization
Secondary outcomes (8)
C-reactive protein (mg/L)
inflammatory markers
Measured: the day before and 24 hours after embolization
Tumor necrosis rate after embolization
technical success indicator
Measured: 1 day and 3 months after embolization
Symptom severity questionnaire
clinical success indicator
Measured: before and 3 months after embolization
White blood cell count (/µL)
inflammatory markers
Measured: the day before and 24 hours after embolization
Neutrophil percentage (%)
inflammatory markers
Measured: the day before and 24 hours after embolization
Cumulative fentanyl dose (µg)
Total amount of IV fentanyl administered
Measured: within 24 hours after embolization
Use of rescue analgesics (%)
Necessity of additional rescue analgesics
Measured: within 24 hours after embolization
Lymphocyte percentage (%)
Inflammatory marker
Measured: the day before and 24 hours after embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Man-Deuk Kim, Principal investigator, Department of Radiology, Severance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960293
- Sponsor's protocol ID
- 4-2021-0467
- Status last verified
- Jul 2021
- First submitted
- 23 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04960293
- Acronym / sponsor ID
- 4-2021-0467
- Conditions
- Symptomatic Uterine Fibroids
- Keywords
- Fibroid, Embolization, Pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spherical gelfoam | Experimental | Procedure: uterine artery embolization using spherical gelfoamPatients who receive uterine artery embolization for symptomatic fibroids |
| Microsphere | Active comparator | Procedure: uterine artery embolization using tri-acryl gelatin microspherePatients who receive uterine artery embolization for symptomatic fibroids |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women with symptomatic fibroids (age: 20 - 60 years old)
Key exclusion criteria (9 listed)
- Bradycardia (<45 bpm)
- Conduction abnormalities
- Liver failure
- renal failure
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine artery embolization using spherical gelfoamUterine artery embolization is performed using spherical gelfoam. All other processes are same. | Procedure or surgery | Spherical gelfoam |
| uterine artery embolization using tri-acryl gelatin microsphereUterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same. | Procedure or surgery | Microsphere |
Primary outcome
Pain score (VAS score)
Time frame: up to 24 hours after embolization
Maximum pain score measured during 24 hours after embolization
8 secondary outcomes
C-reactive protein (mg/L)
Time frame: the day before and 24 hours after embolization
Tumor necrosis rate after embolization
Time frame: 1 day and 3 months after embolization
Symptom severity questionnaire
Time frame: before and 3 months after embolization
White blood cell count (/µL)
Time frame: the day before and 24 hours after embolization
Neutrophil percentage (%)
Time frame: the day before and 24 hours after embolization
Cumulative fentanyl dose (µg)
Time frame: within 24 hours after embolization
Use of rescue analgesics (%)
Time frame: within 24 hours after embolization
Lymphocyte percentage (%)
Time frame: the day before and 24 hours after embolization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man-Deuk Kim principal investigator
Department of Radiology, Severance hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine artery embolization using spherical gelfoam and uterine artery embolization using tri-acryl gelatin microsphere in people with Symptomatic Uterine Fibroids, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Man-Deuk Kim (82-10-8625-2197, mdkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (VAS score) (time frame: up to 24 hours after embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.