Evaluating pH-impedance tracings for GERD classification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to prospectively evaluate pH-impedance tracings in patients with gastroesophageal reflux disease (GERD) by categorizing reasons for discarding reflux episodes identified through automated analysis. The study will manually review these tracings according to the Wingate consensus and assess their impact on GERD classification based on the Lyon consensus. Additionally, it will explore potential confounders such as symptom severity and the use of proton pump inhibitors (PPIs) during the pH-MII procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients aged 18 - 80 years old;
* pH-MII performed off PPI

Exclusion Criteria:

* 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.

Where it's running

• H.u.b
  Anderlecht, Belgium Recruiting
• UZ Brussel
  Jette, Belgium Recruiting
• Technische Universität München
  München, Germany Recruiting

Study contacts

• Study coordinator: Sébastien Kindt, Prof. Dr.
• Email: sebastien.kindt@uzbrussel.be
• Phone: +32 2 477

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.