Uterine MyomaNCT05086770
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
A study testing Gelatin microsphere (Nexsphere™) and Embosphere in people with Uterine Myoma and Uterine Fibroid, run by Next Biomedical Co., Ltd. at 1 site in South Korea.
Trial summary
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women only
- Conditions the study is for
- Uterine Myoma, Uterine Fibroid
- What is being tested?
- Gelatin microsphere (Nexsphere™) and Embosphere
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2021to 30 Nov 2022
- 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 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.
Who cannot join
- Bradycardia on electrocardiogram (< 45 bpm)
- Ventricular conduction abnormalities
- Liver failure
- Kidney failure
- Uncontrolled high blood pressure
- Obesity (BMI ≥ 30 ㎏/㎡)
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- Patients who are allergic to drugs
- Patients who cannot read consent forms such as illiterate or foreigners
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.
Read the detailed description
This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids.
The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization.
Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH).
This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.
- Conditions
- Uterine Myoma, Uterine Fibroid
- Being tested
- Gelatin microsphere (Nexsphere™), Embosphere
- Medical subject headings
- Myofibroma, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin microsphere (Nexsphere™)Device
Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
EmbosphereDevice
Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The test group will be administered 300-500 ㎛ range of Gelatin microsphere (Nexsphere™). A suspension in which a contrast medium and physiological saline are mixed will be administered until the embolization is sufficiently achieved. Receives: Device: Gelatin microsphere (Nexsphere™) |
| Control group | Active comparator | The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved. Receives: Device: Embosphere |
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 hours after embolization
Secondary outcomes (6)
Fentanyl and analgesic usage volume
Fentanyl and analgesic usage volume within 24 hours after embolization
Measured: 24 hours
Symptom severity score
Comparison of symptom severity score before and 3 months after embolization
Symptom was scored on a scale of 0-10, with 0 being no symptoms and 10 being the baseline, or initial symptoms.
Measured: 3 months
Postoperative inflammation
Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization
Measured: 24 hours
Tumor necrosis degree
Assessment of tumor necrosis degree in MR after embolization
Measured: 3 months
Fluoroscopy and procedure time
Fluoroscopy and procedure time taken for embolization to achieved
Measured: procedure time
Serum Anti-Mullerian Hormone (AMH)
Residual ovarian function before and after embolization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start31 May 2021
- Primary completion30 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Man Deuk Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086770
- Sponsor's protocol ID
- NEXTBIO-UIGB-UF01
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han K, Kim SY, Kim MD, Kwon JH, Kim GM, Moon S, Park J, Kim HC, Won JY, Dhahi TMA, Choi J, Kim DK, Yang J, Shin HJ. Resorbable Microspheres versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization: A Randomized Controlled Trial. Radiology. 2024 Sep;312(3):e231525. doi: 10.1148/radiol.231525.
PubMed 39254451
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT05086770
- Acronym / sponsor ID
- NEXTBIO-UIGB-UF01
- Conditions
- Uterine Myoma, Uterine Fibroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Oct 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.
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.
Detailed description
This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids.
The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization.
Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH).
This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Gelatin microsphere (Nexsphere™)The test group will be administered 300-500 ㎛ range of Gelatin microsphere (Nexsphere™). A suspension in which a contrast medium and physiological saline are mixed will be administered until the embolization is sufficiently achieved. |
| Control group | Active comparator | Device: EmbosphereThe control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.
Key exclusion criteria (9 listed)
- Bradycardia on electrocardiogram (< 45 bpm)
- Ventricular conduction abnormalities
- Liver failure
- Kidney failure
- Uncontrolled high blood pressure
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 |
|---|---|---|
| Gelatin microsphere (Nexsphere™)Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection. | Device | Test group |
| EmbosphereTris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion. | Device | Control group |
Primary outcome
Pain intensity by numerical rating scale
Time frame: 0-24 hours after embolization
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
6 secondary outcomes
Fentanyl and analgesic usage volume
Time frame: 24 hours
Symptom severity score
Time frame: 3 months
Postoperative inflammation
Time frame: 24 hours
Tumor necrosis degree
Time frame: 3 months
Fluoroscopy and procedure time
Time frame: procedure time
Serum Anti-Mullerian Hormone (AMH)
Time frame: 3 months
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 14 Jul 2023.
- Derived from this study: PubMed 39254451Han K, Kim SY, Kim MD, Kwon JH, Kim GM, Moon S, Park J, Kim HC, Won JY, Dhahi TMA, Choi J, Kim DK, Yang J, Shin HJ. Resorbable Microspheres versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization: A Randomized Controlled Trial. Radiology. 2024 Sep;312(3):e231525. doi: 10.1148/radiol.231525.
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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, MD, PhD principal investigator
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 Gelatin microsphere (Nexsphere™) and Embosphere in people with Uterine Myoma and Uterine Fibroid, run by Next Biomedical Co., Ltd. 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: finished, as of the sponsor's last update on 14 Jul 2023. 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 hours after embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086770, which also lists 1 linked publication.
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 14 Jul 2023.