GERDWinProNCT06084572
Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
An observational study of GERD, run by Universitair Ziekenhuis Brussel at 3 sites in 2 countries.
Trial summary
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD
- What is being tested?
- Questionnaires
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Sep 2023to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred for pH-MII are eligible.
Who may be able to join
- Adult patients aged 18 - 80 years old;
- pH-MII performed off PPI
Who cannot join
- Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
- Incomplete pH-MII (less than 21 hours recording);
- Ph-MII performed on PPI
- Suboptimal quality of the tracings preventing interpretation in clinical practice;
- Prior oesophageal (including anti-reflux intervention) or gastric surgery.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
H.U.B
Anderlecht, 1080
Hubert Louis, prof. dr., +32 (0)2 555 55 55, hubert.louis@hubruxelles.be
- Recruiting
UZ Brussel
Jette, 1090
Sebastien Kindt, MD, +32 2 477 ext. 60 11, sebastien.kindt@uzbrussel.be
Germany1 site, 1 recruiting
- Recruiting
Technische Universität München
München, 81675
Alissa Jell, dr., +49 (0)89 4140-5023, alissa.jell@tum.de
About this study
Official title: Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on Gastro-oesophageal Reflux Disease (GERD) Classification According to the Lyon Consensus.
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.
Read the detailed description
All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.
- Conditions
- GERD
- Being tested
- Questionnaires
- Keywords
- GERD, pH-impedance, Wingate-consensus, Lyon consensus
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
FSSG \& BEDQ
| Study group | Role | What they receive |
|---|---|---|
| GERD patients | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical difference in the GERD categorisation
the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings
Measured: During baseline visit
Secondary outcomes (8)
The analysis of the influence of different parameters on application of the Wingate criteria: including the Indication for referral with further classification into predominant oesophageal and extra-oesophageal symptoms;
Measured: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;
Measured: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;
Measured: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);
Measured: During baseline visit
Presence of significant correlations between censored episodes and pH-MII parameters
Correlations including:
- Acid exposure time;
- Total number of reflux episodes identified by impedance monitoring;
- MNBI;
- PSPWI.
Measured: During baseline visit
Impact of the Wingate criteria on The number of PSPW;
Measured: During baseline visit
Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.
Measured: During baseline visit
Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux
Measured: During baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start29 Sep 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
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 Universitair Ziekenhuis BrusselThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084572
- Sponsor's protocol ID
- WinPro
- Acronym
- WinPro
- Status last verified
- Mar 2025
- First submitted
- 2 Oct 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on Gastro-oesophageal Reflux Disease (GERD) Classification According to the Lyon Consensus.
- ClinicalTrials.gov ID
- NCT06084572
- Acronym / sponsor ID
- WinPro / WinPro
- Conditions
- GERD
- Keywords
- GERD, pH-impedance, Wingate-consensus, Lyon consensus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 Oct 2023 (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.
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.
Detailed description
All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD patients | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for pH-MII are eligible.
Key inclusion criteria (2 listed)
- Adult patients aged 18 - 80 years old;
- pH-MII performed off PPI
Key exclusion criteria (5 listed)
- Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
- Incomplete pH-MII (less than 21 hours recording);
- Ph-MII performed on PPI
- Suboptimal quality of the tracings preventing interpretation in clinical practice;
- Prior oesophageal (including anti-reflux intervention) or gastric surgery.
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 |
|---|---|---|
| QuestionnairesFSSG \& BEDQ | Other | GERD patients |
Primary outcome
Statistical difference in the GERD categorisation
Time frame: During baseline visit
the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings
8 secondary outcomes
The analysis of the influence of different parameters on application of the Wingate criteria: including the Indication for referral with further classification into predominant oesophageal and extra-oesophageal symptoms;
Time frame: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;
Time frame: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;
Time frame: During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);
Time frame: During baseline visit
Presence of significant correlations between censored episodes and pH-MII parameters
Time frame: During baseline visit
Impact of the Wingate criteria on The number of PSPW;
Time frame: During baseline visit
Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.
Time frame: During baseline visit
Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux
Time frame: During baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Universitair Ziekenhuis Brussel at 3 sites in 2 countries.
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 5 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Kindt, Prof. Dr. (+32 2 477 ext. 60 11, sebastien.kindt@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical difference in the GERD categorisation (time frame: During baseline visit). 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 19 Mar 2025.