Status:
RECRUITING
Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
GERD
Eligibility:
All Genders
18-80 years
Brief 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 th...
Eligibility Criteria
Inclusion
- Adult patients aged 18 - 80 years old;
- pH-MII performed off PPI
Exclusion
- 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.
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06084572
Start Date
September 29 2023
End Date
April 1 2026
Last Update
March 19 2025
Active Locations (3)
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1
H.U.B
Anderlecht, Belgium, 1080
2
UZ Brussel
Jette, Belgium, 1090
3
Technische Universität München
München, Germany, 81675