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NCT01675011 · ClinicalTrials.gov registry record · NA

Embozene Microspheres for Uterine Fibroid Embolization (UFE)

A NA study, sponsored by Boston Scientific Corporation.

Terminated
Registry status
NA
Development phase
4
Enrollment target

NCT01675011: Clinical Trial NA study, sponsored by Boston Scientific Corporation.

NCT01675011 is a NA study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01675011, a NA study, was terminated before completion, sponsored by Boston Scientific Corporation.

TERMINATED
Registry status
NA
Development phase
4 participants
Enrollment target

Study Summary

This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.

Primary Outcome

The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.

Interventions

  • DEVICE Embozene® Microspheres
  • DEVICE Embosphere®

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2012-08
Est. Completion 2013-12
Phase NA
Boston Scientific Corporation

280 total trials

Why NCT01675011 stopped before completion

NCT01675011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Embozene® Microspheres is the first listed.

NCT01675011 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01675011 about?

NCT01675011 is a clinical study titled "Embozene Microspheres for Uterine Fibroid Embolization (UFE)". This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.

What is the current status of trial NCT01675011?

This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2012-08. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01675011?

The interventions under investigation include: Embozene® Microspheres (DEVICE), Embosphere® (DEVICE).

Who is sponsoring clinical trial NCT01675011?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01675011's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01675011, the US trial registry maintained by the National Library of Medicine. NCT01675011 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.