Postablation: Evaluation of the Endometrial Cavity After Endometrial Ablation

• Sponsor: Baylor Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02087228
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 21.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Device: Genesys HydroTherm Ablator; Device: radiofrequency energy ablation device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Endometrial Cavity After Endometrial Ablation
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydrothermal ablation Uterine ablation performed with a device that circulates heated water inside the uterus	Device: Genesys HydroTherm Ablator; Heated water is circulated inside the uterus to destroy the lining of the uterus
Active Comparator: radiofrequency energy ablation performed with a device that uses radiofrequency energy.	Device: radiofrequency energy ablation device

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Measurments of endometrial thickness [6 months post-ablation]

   Measurements will be taken of the uterine cavity length and endometrial thickness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 51 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Health Care	Fort Worth	Texas	United States	76104

Sponsors and Collaborators

• Baylor Research Institute

Investigators

• Principal Investigator: Delbert A Johns, M.D., Texas Health Care, Baylor Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT02087228
• Other Study ID Numbers: 013-053; BRI-2013-1979
• First Posted: Mar 14, 2014
• Last Update Posted: Jan 18, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Baylor Research Institute: Endometrial ablation, menorrhagia
• Additional relevant MeSH terms: Menorrhagia

Study Results

No Results Posted as of Jan 18, 2016