NCT03427671

OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: IMBiotechnologies Ltd. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.

Detailed description

Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres.

Conditions

• Uterine Fibroid
• Myoma
• Leiomyoma

Interventions

Type	Name	Description
DEVICE	Occlusin 500 Microspheres	Occlusin 500 microspheres will be administered using a catheter directed to the uterine vasculature using fluoroscopy. The microsphere suspension will be administered to a near-stasis endpoint.

Timeline

• Start date: 2018-01-17
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2018-02-09
• Last updated: 2019-09-12

Locations

1 site across 1 country: Canada