Evaluation of the Endometrial Cavity After Endometrial Ab... | NCT02087228

Studies
Evaluation of the Endometrial Cavity After Endometrial Ablation

NCT02087228

Sponsor

Baylor Research Institute

Status

Terminated

Last Update Posted

Jan 18, 2016Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Menorrhagia

Interventions

Genesys HydroTherm Ablator
radiofrequency energy ablation device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BRI-2013-1979	Other Identifier	Baylor Research Institute

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor and Principle Investigator mutually agreed to terminate study and patients are no longer examined/treated

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Mar 10, 2014

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2016

Last Update Posted Date

Jan 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Genesys HydroTherm Ablator	Device	Heated water is circulated inside the uterus to destroy the lining of the uterus	Hydrothermal ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Measurments of endometrial thickness	Measurements will be taken of the uterine cavity length and endometrial thickness	6 months post-ablation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

51 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Delbert A Johns, M.D.	Texas Health Care, Baylor Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Health Care		Fort Worth	Texas	76104	United States

Type	Date	Date Unknown
Release	Jan 3, 2024
Reset	Jan 29, 2024
Release	Oct 1, 2025
Reset	Oct 27, 2025
Release	May 1, 2026
Reset	May 26, 2026

Submission Tracking

Estimated Results First Submitted Date

Jan 3, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 3, 2024			Jan 29, 2024
Oct 1, 2025

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided