Evaluation of the Endometrial Cavity After Endometrial Ablation (Postablation)

Baylor Scott and White Health (BSWH)

Status: Terminated

Conditions: Menorrhagia

Treatments: Device: Genesys HydroTherm Ablator; Device: radiofrequency energy ablation device

Study type: Interventional

Funder types: Other

Identifiers

NCT02087228

013-053

BRI-2013-1979 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Hydrothermal ablation

Experimental group

Description:

Uterine ablation performed with a device that circulates heated water inside the uterus

Treatment:

Device: Genesys HydroTherm Ablator

radiofrequency energy

Active Comparator group

Description:

ablation performed with a device that uses radiofrequency energy.

Treatment:

Device: radiofrequency energy ablation device