CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 147 enrolled
Drug / intervention
Intrauterine Ultrasound-Guided Radiofreq. Ablation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02228174
NCT02228174N/ACompleted
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Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance

Gynesonics·interventional·Posted Aug 28, 2014·Updated Feb 11, 2020

In Brief

A clinical study evaluating Intrauterine Ultrasound-Guided Radiofreq. Ablation System for Menorrhagia. Completed, enrolled 147 participants across 23 sites in 2 countries.

Detailed Summary

The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
CountriesMexico, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 28, 2014
Enrollment StartOct 1, 2014
Primary CompletionOct 18, 2017
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.8 years ago

Interventions

Intrauterine Ultrasound-Guided Radiofreq. Ablation Systemdevice

The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).