Evaluation of the Endometrial Cavity After Endometrial Ablation

Not Applicable

Terminated

• Conditions: Menorrhagia
• Interventions: Device: Genesys HydroTherm Ablator; Device: radiofrequency energy ablation device

• Registration Number: NCT02087228
• Lead Sponsor: Baylor Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrothermal ablation	Genesys HydroTherm Ablator	Uterine ablation performed with a device that circulates heated water inside the uterus
radiofrequency energy	radiofrequency energy ablation device	ablation performed with a device that uses radiofrequency energy.

Primary Outcome Measures

Name	Time	Method
Visualization of the inside of the uterus	6 months post-ablation	The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring

Secondary Outcome Measures

Name	Time	Method
Measurments of endometrial thickness	6 months post-ablation	Measurements will be taken of the uterine cavity length and endometrial thickness

Trial Locations

Locations (1)

Texas Health Care; 🇺🇸 Fort Worth, Texas, United States