Trials / Completed
CompletedNCT02228174
Sonography Guided Transcervical Ablation of Uterine Fibroids
Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- Gynesonics · Industry
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Detailed description
In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intrauterine Ultrasound-Guided Radiofreq. Ablation System | 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). |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2017-10-18
- Completion
- 2019-11-01
- First posted
- 2014-08-28
- Last updated
- 2020-02-11
- Results posted
- 2019-02-19
Locations
23 sites across 2 countries: United States, Mexico
Source: ClinicalTrials.gov record NCT02228174. Inclusion in this directory is not an endorsement.