Uterine Fibroid Clinical Trial
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
Verified date | July 2023 |
Source | Next Biomedical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 59 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Next Biomedical Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity by numerical rating scale | 0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable | 0-24 hours after embolization | |
Secondary | Fentanyl and analgesic usage volume | Fentanyl and analgesic usage volume within 24 hours after embolization | 24 hours | |
Secondary | 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. |
3 months | |
Secondary | Postoperative inflammation | Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization | 24 hours | |
Secondary | Tumor necrosis degree | Assessment of tumor necrosis degree in MR after embolization | 3 months | |
Secondary | Fluoroscopy and procedure time | Fluoroscopy and procedure time taken for embolization to achieved | procedure time | |
Secondary | Serum Anti-Mullerian Hormone (AMH) | Residual ovarian function before and after embolization | 3 months |
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