Trials / Recruiting
RecruitingNCT06084572
Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
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.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (estimated)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Questionnaires | FSSG \& BEDQ |
Timeline
- Start date
- 2023-09-29
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2023-10-16
- Last updated
- 2025-03-19
Locations
3 sites across 2 countries: Belgium, Germany
Source: ClinicalTrials.gov record NCT06084572. Inclusion in this directory is not an endorsement.