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NCT02228174 · ClinicalTrials.gov registry record · NA
Sonography Guided Transcervical Ablation of Uterine Fibroids
A NA study of Menorrhagia, sponsored by Gynesonics.
- Completed
- Registry status
- NA
- Development phase
- 147
- Enrollment target
- 20
- Study locations
NCT02228174: Completed NA study of Menorrhagia, sponsored by Gynesonics.
NCT02228174 is a NA study of Menorrhagia that has completed, run by Gynesonics. The registered enrollment target is 147 participants, below the 214-participant average among 10 other Menorrhagia trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228174, a NA study of Menorrhagia, has completed, sponsored by Gynesonics.
- COMPLETED
- Registry status
- NA
- Development phase
- 147 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Primary Outcome
The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score \< 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women wer
Conditions Studied
Interventions
- DEVICE Intrauterine Ultrasound-Guided Radiofreq. Ablation System
Study Locations (20)
Florida
- KO Clinical Research, LLC - Fort Lauderdale
- Visions Clinical Research - Wellington
Pennsylvania
- Drexel University - Philadelphia
- Magee Women's Hospital - Pittsburgh
Texas
- Baylor Research Institute - Fort Worth
- Willowbend Health and Wellness Associates - Frisco
Arizona
- Kelly H. Roy M.D. P.C. - Phoenix
Colorado
- Advanced Women's Health Institute - Denver
Delaware
- Christiana Care Health Services, Inc. - Newark
District of Columbia
- George Washington University Hospital - Washington D.C.
Illinois
- The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates - Naperville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-11 |
| Phase | NA |
What the finished NCT02228174 record still lists
NCT02228174 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 214-participant average among 10 other Menorrhagia trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 1 intervention - of which Intrauterine Ultrasound-Guided Radiofreq. Ablation System is the first listed.
NCT02228174 names 20 study sites across 17 states, led by Florida, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT02228174 about?
NCT02228174 is a clinical study titled "Sonography Guided Transcervical Ablation of Uterine Fibroids". The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
What is the current status of trial NCT02228174?
This trial is currently completed. It is a NA study. The enrollment target is 147 participants. The study started on 2014-10. Estimated completion is 2019-11.
What conditions does trial NCT02228174 study?
This clinical trial studies the following conditions: Menorrhagia.
What interventions are being tested in trial NCT02228174?
The interventions under investigation include: Intrauterine Ultrasound-Guided Radiofreq. Ablation System (DEVICE).
Who is sponsoring clinical trial NCT02228174?
This trial is sponsored by Gynesonics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02228174 being conducted?
This trial has 20 study locations across Arizona, Colorado, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Menorrhagia
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 NCT02228174's enrollment target sits among peer trials
147 8th of 10 higher than 3 of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia 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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