An interventional study of Gelatin microsphere (Nexsphere™) and Embosphere in Uterine Myoma and Uterine Fibroid, sponsored by Next Biomedical Co., Ltd.. Completed at 1 site in South Korea. Open to female participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Next Biomedical Co., Ltd. · Not applicable, Interventional, and Treatment
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.
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.
344 studies on the registry are indexed under Myofibroma; 41 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 244 interventional studies indexed under Myofibroma.
Browse Myofibroma studies →Next Biomedical Co., Ltd. is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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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.
Device: Gelatin microsphere (Nexsphere™)
The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.
Device: Embosphere
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.
Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
Pain intensity by numerical rating scale
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
Time frame: 0-24 hours after embolization
Fentanyl and analgesic usage volume
Fentanyl and analgesic usage volume within 24 hours after embolization
Time frame: 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.
Time frame: 3 months
Postoperative inflammation
Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization
Time frame: 24 hours
Tumor necrosis degree
Assessment of tumor necrosis degree in MR after embolization
Time frame: 3 months
Fluoroscopy and procedure time
Fluoroscopy and procedure time taken for embolization to achieved
Time frame: procedure time
Serum Anti-Mullerian Hormone (AMH)
Residual ovarian function before and after embolization
Time frame: 3 months
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Next Biomedical Co., Ltd.