NCT02087228

Evaluation of the Endometrial Cavity After Endometrial Ablation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DEVICE	Genesys HydroTherm Ablator	Heated water is circulated inside the uterus to destroy the lining of the uterus
DEVICE	radiofrequency energy ablation device

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-03-14
• Last updated: 2016-01-18

Locations

1 site across 1 country: United States