Evaluation of the Endometrial Cavity After Endometrial Ablation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.

Detailed Description
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The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device. A vaginal ultrasound will be performed before the procedure and again at six months post-procedure. The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.

Official Title
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Evaluation of the Endometrial Cavity After Endometrial Ablation

Conditions
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Menorrhagia

Intervention / Treatment
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* Device: Genesys HydroTherm Ablator
* Device: radiofrequency energy ablation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation Exclusion Criteria: Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrothermal ablation<br>Uterine ablation performed with a device that circulates heated water inside the uterus | Device: Genesys HydroTherm Ablator<br>* Heated water is circulated inside the uterus to destroy the lining of the uterus<br>|
| Active Comparator: radiofrequency energy<br>ablation performed with a device that uses radiofrequency energy. | Device: radiofrequency energy ablation device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of the inside of the uterus | The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring | 6 months post-ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurments of endometrial thickness | Measurements will be taken of the uterine cavity length and endometrial thickness | 6 months post-ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial ablation, menorrhagia