Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-20

Study Completion Date

2018-08-27

Brief Summary

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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.

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Detailed Description

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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

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Uterine Fibroids Adhesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fibroid Treatment

Intrauterine ultrasound guided radio-frequency ablation

Intervention Type DEVICE

Radiofrequency ablation for the treatment of uterine fibroids

Interventions

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Intrauterine ultrasound guided radio-frequency ablation

Radiofrequency ablation for the treatment of uterine fibroids

Intervention Type DEVICE

Other Intervention Names

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Sonata System

Eligibility Criteria

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Inclusion Criteria

* Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
* Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
* Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements

Exclusion Criteria

* Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
* One or more Type 0 fibroids and/or endometrial polyps of any size
* Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No