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

Nextbiomedical

Status: Completed

Conditions: Uterine Fibroid; Uterine Myoma

Treatments: Device: Embosphere; Device: Gelatin microsphere (Nexsphere™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05086770

NEXTBIO-UIGB-UF01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Device: Gelatin microsphere (Nexsphere™)

Control group

Active Comparator group

Description:

The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved.

Treatment:

Device: Embosphere