LeiomyomaNCT03420248
Comparison of Pain of Two Different Methods in Uterine Artery Embolization
A study testing Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere in people with Leiomyoma, run by Severance Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2018to 8 May 2019
- 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
- Uterine artery embolization due to multiple fibroids
Who cannot join
- Severe liver or kidney dysfunction
- Drug allergy
- Bradycardia (<45 bpm) or heart block
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sesverance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
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
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
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 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
- Conditions
- Leiomyoma
- Being tested
- Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphereDevice
One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.
| Study group | Role | What they receive |
|---|---|---|
| Non-spherical polyvinyl alcohol particle | Experimental | For embolic material, non-spherical polyvinyl alcohol particle is used. Receives: Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere |
| Tris-acryl gelatin microsphere | Experimental | For embolic material, Tris-acryl gelatin microsphere is used. Receives: Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity by numerical rating scale
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
Measured: 0-24 h after UAE
Secondary outcomes (7)
C-reactive protein
mg/L
Measured: 24 h after UAE
White blood cell count
/uL
Measured: 24 h after UAE
Neutrophil percentage
Measured: 24 h after UAE
Neutrophil-to-lymphocyte ratio
Measured: 24 h after UAE
Platelet-to-lymphocyte ratio
Measured: 24 h after UAE
Mean platelet volume
fL(femtolitre)
Measured: 24 h after UAE
Sucessful rate at 3 month after UAE measured by MRI
Complete necrosis incidence
Measured: 3 month after UAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start19 Apr 2018
- Primary completion8 Feb 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
- Investigators
- So Yeon Kim, MD, PhD, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of MedicineMan Deuk Kim, MD, PhD, Principal investigator, Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420248
- Sponsor's protocol ID
- 4-2016-1108
- Status last verified
- Sep 2019
- First submitted
- 16 Jan 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03420248
- Acronym / sponsor ID
- 4-2016-1108
- Conditions
- Leiomyoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 5 Feb 2018 (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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-spherical polyvinyl alcohol particle | Experimental | Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphereFor embolic material, non-spherical polyvinyl alcohol particle is used. |
| Tris-acryl gelatin microsphere | Experimental | Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphereFor embolic material, Tris-acryl gelatin microsphere is used. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Uterine artery embolization due to multiple fibroids
Key exclusion criteria (4 listed)
- Severe liver or kidney dysfunction
- Drug allergy
- Bradycardia (<45 bpm) or heart block
- 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 |
|---|---|---|
| Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphereOne of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same. | Device | Non-spherical polyvinyl alcohol particle, Tris-acryl gelatin microsphere |
Primary outcome
Pain intensity by numerical rating scale
Time frame: 0-24 h after UAE
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
7 secondary outcomes
C-reactive protein
Time frame: 24 h after UAE
White blood cell count
Time frame: 24 h after UAE
Neutrophil percentage
Time frame: 24 h after UAE
Neutrophil-to-lymphocyte ratio
Time frame: 24 h after UAE
Platelet-to-lymphocyte ratio
Time frame: 24 h after UAE
Mean platelet volume
Time frame: 24 h after UAE
Sucessful rate at 3 month after UAE measured by MRI
Time frame: 3 month after UAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Leiomyoma
Active, not recruiting
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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.
So Yeon Kim, MD, PhD principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Man Deuk Kim, MD, PhD principal investigator
Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere in people with Leiomyoma, run by Severance Hospital 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 4 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: finished, as of the sponsor's last update on 19 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity by numerical rating scale (time frame: 0-24 h after UAE). 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 19 Sep 2019.