Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (OPEN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02844920|
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment|
|Uterine Fibroids Adhesions||Device: Intrauterine ultrasound guided radio-frequency ablation|
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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids|
|Actual Study Start Date :||July 20, 2017|
|Actual Primary Completion Date :||August 27, 2018|
|Actual Study Completion Date :||August 27, 2018|
Intrauterine ultrasound guided radio-frequency ablation
Device: Intrauterine ultrasound guided radio-frequency ablation
Radiofrequency ablation for the treatment of uterine fibroids
Other Name: Sonata System
- Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids [ Time Frame: 6 weeks ]Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
- Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated [ Time Frame: 6 weeks ]As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844920
|Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg|
|Mannheim, Germany, 68167|
|Maxima Medisch Centrum (MMC)|
|Universitätsklinik für Frauenheilkunde Inselspital Bern|
|St. Mary's Hospital|
|London, United Kingdom|