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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02844920
Study type Observational
Source Gynesonics
Contact
Status Completed
Phase
Start date July 20, 2017
Completion date August 27, 2018

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