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NCT01377519 · ClinicalTrials.gov registry record · NA

Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

A NA study of Uterine Fibroids, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT01377519: Completed NA study of Uterine Fibroids, sponsored by University of California, San Francisco.

NCT01377519 is a NA study of Uterine Fibroids that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 242-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01377519, a NA study of Uterine Fibroids, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.

Conditions Studied

Interventions

  • PROCEDURE MR Guided Focused Ultrasound
  • PROCEDURE Placebo MR Guided Focused Ultrasound

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-06
Est. Completion 2012-12
Phase NA

What the finished NCT01377519 record still lists

NCT01377519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 242-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Uterine Fibroids appearing as the primary indexed condition, and to 2 interventions - of which MR Guided Focused Ultrasound is the first listed.

NCT01377519 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01377519 about?

NCT01377519 is a clinical study titled "Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids". This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The...

What is the current status of trial NCT01377519?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2012-12.

What conditions does trial NCT01377519 study?

This clinical trial studies the following conditions: Uterine Fibroids.

What interventions are being tested in trial NCT01377519?

The interventions under investigation include: MR Guided Focused Ultrasound (PROCEDURE), Placebo MR Guided Focused Ultrasound (PROCEDURE).

Who is sponsoring clinical trial NCT01377519?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01377519 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Uterine Fibroids

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01377519's enrollment target sits among peer trials

20 11th of 10 the lowest of 10 other Uterine Fibroids trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Uterine Fibroids 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 NCT01377519, the US trial registry maintained by the National Library of Medicine. NCT01377519 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.