Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377519
The ClinicalTrials.gov registry entry for NCT01377519 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (92% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
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.
-
An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
RECRUITING · NA
-
Uterine Leiomyoma Treatment With Radiofrequency Ablation
COMPLETED · NA
-
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
COMPLETED · NA
-
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
RECRUITING · Phase 3
-
Effect of Addition of Steroids on Duration of Analgesia
ACTIVE NOT RECRUITING · Early Phase 1
-
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
ACTIVE NOT RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.