Evaluation of the Endometrial Cavity After Endometrial Ablation

NCT02087228 | Terminated

• 2 other identifiers: 013-053BRI-2013-1979
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Keywords

Endometrial ablation, menorrhagia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Measurments of endometrial thickness

  6 months post-ablation

Study Arms (2)

Hydrothermal ablation

EXPERIMENTAL

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

Device: Genesys HydroTherm Ablator

radiofrequency energy

ACTIVE COMPARATOR

ablation performed with a device that uses radiofrequency energy.

Device: radiofrequency energy ablation device

Interventions

Genesys HydroTherm Ablator DEVICE

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

Hydrothermal ablation

radiofrequency energy ablation device DEVICE

radiofrequency energy

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Texas Health Care

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Delbert A Johns, M.D.

  Texas Health Care, Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 14, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)