Menorrhagia
Conditions
Keywords
Endometrial ablation, menorrhagia
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.
Interventions
DEVICEGenesys HydroTherm Ablator
Heated water is circulated inside the uterus to destroy the lining of the uterus
DEVICEradiofrequency energy ablation device
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Measurments of endometrial thickness | 6 months post-ablation | Measurements will be taken of the uterine cavity length and endometrial thickness |
Countries
United States
Outcome results
None listed