Evaluation of the Endometrial Cavity After Endometrial Ablation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

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.

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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.

Conditions

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Menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrothermal ablation

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

Group Type EXPERIMENTAL

Genesys HydroTherm Ablator

Intervention Type DEVICE

Heated water is circulated inside the uterus to destroy the lining of the uterus

radiofrequency energy

ablation performed with a device that uses radiofrequency energy.

Group Type ACTIVE_COMPARATOR

radiofrequency energy ablation device

Intervention Type DEVICE

Interventions

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Genesys HydroTherm Ablator

Heated water is circulated inside the uterus to destroy the lining of the uterus

Intervention Type DEVICE

radiofrequency energy ablation device

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No