Gastroesophageal Reflux Disease Prospective Registry | NCT02479438

Studies
Gastroesophageal Reflux Disease Prospective Registry

NCT02479438

Sponsor

Baylor Research Institute

Status

Terminated

Last Update Posted

May 22, 2025Actual

Enrollment

744Actual

Phase

Not provided

Conditions

GERD

Interventions

Diagnosed with GERD

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated by the Principal Investigator's to redesign it using more efficient processes.

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Sep 2024Actual

Completion Date

Sep 2024Actual

First Submitted Date

May 7, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 24, 2015Estimated

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

May 21, 2025

Last Update Posted Date

May 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

Detailed Description

All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

744Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnosed with GERD		Collect data on GERD patients	Other: Diagnosed with GERD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnosed with GERD	Other	Recording of patient outcomes	Diagnosed with GERD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative patient reported sign and symptoms	Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire.	Up to 10 years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Any patient undergoing anti-reflux surgery

Exclusion Criteria:

- None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Leeds, MD	Baylor Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor Research University Medical Center		Dallas	Texas	75246	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided