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Comparison of Pain After Uterine Artery Embolization Using Spherical Gelfoam or Tris-acryl Gelatin Microsphere

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ClinicalTrials.gov Identifier: NCT05086770
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Next Biomedical Co., Ltd.

Brief Summary:
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.

Condition or disease Intervention/treatment Phase
Uterine Myoma Uterine Fibroid Device: Spherical Gelfoam (Nexsphere™) Device: Embosphere Not Applicable

Detailed Description:

This investigational study is designed to compare pain after uterine artery embolization using spherical gelfoam 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2021
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

Arm Intervention/treatment
Experimental: Test group
The test group will be administered 300-500 ㎛ range of Spherical Gelfoam (Nexsphere™). A suspension in which a contrast medium and physiological saline are mixed will be administered until the embolization is sufficiently achieved.
Device: Spherical Gelfoam (Nexsphere™)
Spherical Gelfoam (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 spherical gel foam 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.

Active Comparator: Control group
The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.
Device: Embosphere
Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fentanyl and analgesic usage volume [ Time Frame: 24 hours ]
    Fentanyl and analgesic usage volume within 24 hours after embolization

  2. Symptom severity score [ Time Frame: 3 months ]

    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.


  3. Postoperative inflammation [ Time Frame: 24 hours ]
    Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization

  4. Tumor necrosis degree [ Time Frame: 3 months ]
    Assessment of tumor necrosis degree in MR after embolization

  5. Fluoroscopy and procedure time [ Time Frame: procedure time ]
    Fluoroscopy and procedure time taken for embolization to achieved

  6. Serum Anti-Mullerian Hormone (AMH) [ Time Frame: 3 months ]
    Residual ovarian function before and after embolization



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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.

Exclusion Criteria:

  • Bradycardia on electrocardiogram (< 45 bpm)
  • Ventricular conduction abnormalities
  • Liver failure
  • Kidney failure
  • Uncontrolled high blood pressure
  • Obesity (BMI ≥ 30 ㎏/㎡)
  • Patients who are allergic to drugs
  • Patients who cannot read consent forms such as illiterate or foreigners
  • Pregnant woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086770


Contacts
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Contact: Jin Hee Maeng, MS 82-32-880-0860 jhmaeng@nextbiomedical.co.kr

Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Man Deuk Kim, MD, PhD    82-1599-1004    mdkim@yuhs.ac   
Sponsors and Collaborators
Next Biomedical Co., Ltd.
Investigators
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Principal Investigator: Man Deuk Kim, MD, PhD Severance Hospital
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Responsible Party: Next Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05086770    
Other Study ID Numbers: NEXTBIO-UIGB-UF01
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Gelatin Sponge, Absorbable
Hemostatics
Coagulants