Evaluation of the Endometrial Cavity After Endometrial Ablation

Menorrhagia Clinical Trial

— Postablation  

Official title:

Evaluation of the Endometrial Cavity After Endometrial Ablation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02087228
• Other study ID #: 013-053
• Secondary ID: BRI-2013-1979
• Status: Terminated
• Phase: N/A
• First received: March 10, 2014
• Last updated: January 15, 2016
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• Genesys HydroTherm Ablator
Heated water is circulated inside the uterus to destroy the lining of the uterus
• radiofrequency energy ablation device

Locations

Country	Name	City	State
United States	Texas Health Care	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of the inside of the uterus	The inside of the uterus will be visualized via hysteroscopy to determine the amount of scarring	6 months post-ablation	No
Secondary	Measurments of endometrial thickness	Measurements will be taken of the uterine cavity length and endometrial thickness	6 months post-ablation	No