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

NCT02410018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-12-05

Study results available
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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.

Conditions

  • Leiomyomata

Interventions

DEVICE

OCL 503 (uterine artery embolization)

Transcatheter embolization of the uterine artery(ies) using an embolic agent.

Sponsors & Collaborators

  • IMBiotechnologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Gary Siskin, MD · Albany Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410018 on ClinicalTrials.gov