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NCT01840124 · ClinicalTrials.gov registry record · NA
Uterine Leiomyoma Treatment With Radiofrequency Ablation
A NA study of Uterine Fibroids, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 5
- Study locations
NCT01840124 is a NA study of Uterine Fibroids that has completed, run by University of California, San Francisco. The registered enrollment target is 26 participants, below the 242-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT01840124, a NA study of Uterine Fibroids, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 5
- Study locations
Study Summary
The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure. The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure. Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring board will oversee participant safety and protection.
Conditions Studied
Interventions
- PROCEDURE Radiofrequency ablation of fibroids
Study Locations (5)
California
- University of California, Davis - Davis
- University of California, Irivine - Irvine
- University of California, San Diego - La Jolla
- University of California, Los Angeles - Los Angeles
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-07 |
| Est. Completion | 2020-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01840124
The ClinicalTrials.gov registry entry for NCT01840124 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 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 (89% 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 1 intervention - of which Radiofrequency ablation of fibroids is the first listed.
NCT01840124 reports 5 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01840124 about?
NCT01840124 is a clinical study titled "Uterine Leiomyoma Treatment With Radiofrequency Ablation". The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fi...
What is the current status of trial NCT01840124?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2013-07. Estimated completion is 2020-01.
What conditions does trial NCT01840124 study?
This clinical trial studies the following conditions: Uterine Fibroids.
What interventions are being tested in trial NCT01840124?
The interventions under investigation include: Radiofrequency ablation of fibroids (PROCEDURE).
Who is sponsoring clinical trial NCT01840124?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01840124 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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