GERDNCT05089929
Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM)
An observational study of GERD, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Endoflip 2.0 and High Resolution Manometry
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Suspected or known history of GERD
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM) in Pre-operative Evaluation of GERD; a Non-inferiority Trial
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).
Read the detailed description
The goal of the proposed research is to evaluate the endoscopic esophageal functional luminal imaging probe (FLIP) with topography (Endoflip® 2.0, Medtronic, USA) as a pre-operative diagnostic test to rule out significant esophageal dysmotility in patients with gastroesophageal reflux disease (GERD). Currently, the gold standard for pre-operative motility assessment is high resolution manometry (HRM), a trans-nasal catheter test performed in an awake patient that can be quite uncomfortable, and some patients cannot tolerate.1 Conversely, Endoflip can provide similar data in a sedated patient at the time of upper endoscopy, limiting discomfort and streamlining workup. While Endoflip has been used as a complimentary tool for clinical decision making in major motility disorders, its evaluation as a potential stand-alone pre-operative test in the GERD population has been limited. However, if FLIP topography reliably excludes major motility disorders, patients could proceed with fundoplication without undergoing the additional burden of high resolution manometry (HRM) testing. Unfortunately, as of now, there are insufficient data available to justify a change in clinical practice. As a result, FLIP topography has remained relegated to a purely complimentary role.
To investigate this question, 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. Those patients with repetitive antegrade contractions (RACs) on FLIP topography will be classified as having normal motility, while any other pattern will be considered abnormal. All patients will additionally complete a standard pre-operative reflux evaluation including HRM, Upper GI series (UGI), 48-hour wireless pH testing, and baseline GERD quality of life surveys. The investigators will then compare the results of the FLIP topography measurements to the results of the gold standard high-resolution manometry (HRM) in terms of the ability of the FLIP topography to differentiate between normal and impaired esophageal function in GERD patients. Subjects will then be followed through their anti-reflux operations and post-operative outcomes will be tracked with standardized symptom questionnaires at 1, 2 and 6 months post-operatively to evaluate for post-operative dysphagia and quality of life.
The investigators hypothesize that FLIP topography (Endoflip 2.0) in GERD patients will reliably identify individuals with normal motility, which will predict good outcomes after anti-reflux surgery. If this proves to be the case, formal high resolution manometry (HRM) testing would not be necessary prior to proceeding with fundoplication, allowing a paradigm shift in the pre-operative workup of this large population of patients.
- Conditions
- GERD
- Being tested
- Endoflip 2.0, High Resolution Manometry
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoflip 2.0Device
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.
High Resolution ManometryProcedure or surgery
All patients undergoing routine evaluation for gastroesophageal reflux disease will undergo high resolution manometry (HRM) testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Endoflip 2.0; Procedure: High Resolution Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Concordance between the presence of RACs versus distal esophageal amplitude
Evaluate the concordance between the presence of RACs on FLIP topography versus the finding of distal esophageal amplitude >20mmHg as a surrogate for adequate esophageal function for Nissen fundoplication.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start19 Mar 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Haisley, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089929
- Sponsor's protocol ID
- 2020H0057
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM) in Pre-operative Evaluation of GERD; a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05089929
- Acronym / sponsor ID
- 2020H0057
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The goal of the proposed research is to evaluate the endoscopic esophageal functional luminal imaging probe (FLIP) with topography (Endoflip® 2.0, Medtronic, USA) as a pre-operative diagnostic test to rule out significant esophageal dysmotility in patients with gastroesophageal reflux disease (GERD). Currently, the gold standard for pre-operative motility assessment is high resolution manometry (HRM), a trans-nasal catheter test performed in an awake patient that can be quite uncomfortable, and some patients cannot tolerate.1 Conversely, Endoflip can provide similar data in a sedated patient at the time of upper endoscopy, limiting discomfort and streamlining workup. While Endoflip has been used as a complimentary tool for clinical decision making in major motility disorders, its evaluation as a potential stand-alone pre-operative test in the GERD population has been limited. However, if FLIP topography reliably excludes major motility disorders, patients could proceed with fundoplication without undergoing the additional burden of high resolution manometry (HRM) testing. Unfortunately, as of now, there are insufficient data available to justify a change in clinical practice. As a result, FLIP topography has remained relegated to a purely complimentary role.
To investigate this question, 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. Those patients with repetitive antegrade contractions (RACs) on FLIP topography will be classified as having normal motility, while any other pattern will be considered abnormal. All patients will additionally complete a standard pre-operative reflux evaluation including HRM, Upper GI series (UGI), 48-hour wireless pH testing, and baseline GERD quality of life surveys. The investigators will then compare the results of the FLIP topography measurements to the results of the gold standard high-resolution manometry (HRM) in terms of the ability of the FLIP topography to differentiate between normal and impaired esophageal function in GERD patients. Subjects will then be followed through their anti-reflux operations and post-operative outcomes will be tracked with standardized symptom questionnaires at 1, 2 and 6 months post-operatively to evaluate for post-operative dysphagia and quality of life.
The investigators hypothesize that FLIP topography (Endoflip 2.0) in GERD patients will reliably identify individuals with normal motility, which will predict good outcomes after anti-reflux surgery. If this proves to be the case, formal high resolution manometry (HRM) testing would not be necessary prior to proceeding with fundoplication, allowing a paradigm shift in the pre-operative workup of this large population of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoflip 2.0 | – | Device: Endoflip 2.0, Procedure: High Resolution ManometryThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Suspected or known history of GERD
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoflip 2.0FLIP 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. | Device | Endoflip 2.0 |
| High Resolution ManometryAll patients undergoing routine evaluation for gastroesophageal reflux disease will undergo high resolution manometry (HRM) testing. | Procedure or surgery | Endoflip 2.0 |
Primary outcome
Concordance between the presence of RACs versus the absence of major motility disorder
Time frame: 6 months
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.
1 secondary outcome
Concordance between the presence of RACs versus distal esophageal amplitude
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between the presence of RACs versus the absence of major motility disorder (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.