Trials / Completed
CompletedNCT02844920
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 37 (actual)
- Sponsor
- Gynesonics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
Detailed description
Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions. Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intrauterine ultrasound guided radio-frequency ablation | Radiofrequency ablation for the treatment of uterine fibroids |
Timeline
- Start date
- 2017-07-20
- Primary completion
- 2018-08-27
- Completion
- 2018-08-27
- First posted
- 2016-07-26
- Last updated
- 2019-09-20
- Results posted
- 2019-09-20
Locations
6 sites across 4 countries: Germany, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02844920. Inclusion in this directory is not an endorsement.