NCT02410018

Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata Scheduled for Hysterectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: IMBiotechnologies Ltd. · Industry
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for hysterectomy.

Detailed description

Patients will be allocated to Cohort 1 or Cohort 2. Following pelvic angiogram to delineate the uterine vasculature, embolization procedures of the left and right uterine arteries (as required) will be performed on each patient, using OCL 503 as the embolic agent. Patients in Cohort 1 will proceed to hysterectomy 1 week after embolization, and patients in Cohort 2 will undergo hysterectomy 1 month after embolization. Tumor response, as measured by changes in leiomyomata size and perfusion, will be determined by Magnetic Resonance Imaging or Magnetic Resonance Angiography. Histology of the resected uterus will be conducted to evaluate inflammatory response and viable tumour tissue.

Conditions

• Leiomyomata

Interventions

Type	Name	Description
DEVICE	OCL 503 (uterine artery embolization)	Transcatheter embolization of the uterine artery(ies) using an embolic agent.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-04-07
• Last updated: 2018-12-05
• Results posted: 2018-09-07

Locations

1 site across 1 country: United States