Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus

NCT06084572 | Recruiting

• 1 other identifier: WinPro
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief Summary

Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.

Conditions

GERD

Keywords

GERD; pH-impedance; Wingate-consensus; Lyon consensus

Outcome Measures

Primary Outcomes (1)

• 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

  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;

  During baseline visit

• The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;

  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;

  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);

  During baseline visit

• Presence of significant correlations between censored episodes and pH-MII parameters

  During baseline visit

Study Arms (1)

GERD patients

Other: Questionnaires

Interventions

Questionnaires OTHER

FSSG \& BEDQ

GERD patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred for pH-MII are eligible.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (3)

H.U.B

Anderlecht, 1080, Belgium

RECRUITING

UZ Brussel

Jette, 1090, Belgium

RECRUITING

Technische Universität München

München, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Sébastien Kindt, Prof. Dr.

CONTACT

+32 2 477; sebastien.kindt@uzbrussel.be

Virgini Van Buggenhout

CONTACT

+32 2 477; virgini.vanbuggenhout@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 16, 2023
• Study Start: September 29, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); DE (1)