Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM)
1 other identifier
observational
55
1 country
1
Brief Summary
The purpose of the study is to investigate the use of FLIP topography in patients undergoing evaluation for gastroesophageal reflux disease (GERD). This device allows the clinician to measure muscle activity in the esophagus during a routine upper endoscopy. The FLIP topography will be used to help detect movement disorders in the esophagus, and to examine differences in patient satisfaction between FLIP topography and the standard of care procedure, high resolution manometry (HRM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2020
CompletedFirst Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedOctober 24, 2023
October 1, 2023
2.8 years
June 14, 2021
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Concordance between the presence of RACs versus the absence of major motility disorder
Evaluate the concordance between the presence of RACs on FLIP topography versus the absence of major motility disorder on HRM as defined by the Chicago classification system v3.
6 months
Secondary Outcomes (1)
Concordance between the presence of RACs versus distal esophageal amplitude
6 months
Other Outcomes (2)
Evaluate patient satisfaction using study questionnaire
6 months
Post-Fundoplication Dysphagia
6 months
Study Arms (1)
Endoflip 2.0
The investigators will perform FLIP topography (Endoflip 2.0) analysis on all patients undergoing routine evaluation for gastroesophageal reflux disease at the time of their pre-operative EGD.
Interventions
FLIP topography (Endoflip 2.0) analysis will be performed on all patients undergoing routine evaluation for gastroesophageal reflux disease at the time of their pre-operative EGD.
All patients undergoing routine evaluation for gastroesophageal reflux disease will undergo high resolution manometry (HRM) testing.
Eligibility Criteria
All patients who present to our comprehensive esophageal clinic for evaluation of suspected GERD meeting the inclusion/exclusion criteria will be asked to participate in the study.
You may qualify if:
- Suspected or known history of GERD
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Previous esophageal or gastric surgery (including failed anti-reflux operation)
- Hiatal Hernia \> 5cm based on upper GI
- Patients with a known major motility disorder (achalasia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 14, 2021
First Posted
October 22, 2021
Study Start
March 19, 2020
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
October 24, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share