NCT02479438

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

10.7 years

First QC Date

May 7, 2015

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Diagnosed with GERD

Collect data on GERD patients

Other: Diagnosed with GERD

Interventions

Recording of patient outcomes

Diagnosed with GERD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- Any patient undergoing anti-reflux surgery

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Research University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Steven Leeds, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

June 24, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations