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NCT02884960

Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids

Status unknown NA Last updated 30 August 2016
What this trial tests

NA trial testing Uterine Fibroid Embolization in Uterine Fibroids in 118 participants. Status unknown.

Timeline
1 October 2016
Primary endpoint
1 October 2017
1 October 2018

Quick facts

Lead sponsorGary Siskin, MD
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment118
Start date1 October 2016
Primary completion1 October 2017
Estimated completion1 October 2018

Drugs / interventions tested

Conditions studied

Sponsor

Gary Siskin, MD

Who can join

Adults 30 to 50, female only, with Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Updates on Uterine Artery Embolization.
    Kohi MP, Spies JB. · · 2018 · cited 38× · PMID 29628616 · DOI 10.1055/s-0038-1636521

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Other recruiting trials for Uterine Fibroids

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02884960.

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