Skip to main content
OpenTrials
Completed

NCT Number: NCT05452603

Usefulness of Wireless pH Monitoring in GERD Diagnosis

Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area.

The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, B1622, Argentina

About this study

Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.

A 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET>6% and the 4 days with AET<4% will be recorded.

Patients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age, with symptoms of gastroesophageal reflux, who have undergone a 24-hour impedance pH study without proton pump inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .

Exclusion criteria

  • Patients with severe comorbidities: Liver cirrhosis, oncological disease, autoimmune diseases, cognitive impairment, psychiatric diseases, bleeding diathesis or anticoagulation
  • Pregnant women
  • Patients with severe esophagitis, esophageal varices, esophageal strictures, Barrett's esophagus, anti-reflux surgery
  • Patients with history of pacemaker or defibrillator, since they can interfere with the signal.
  • Patients with nickel allergy
  • Patients that refuses to sign the informed consent.

Treatment and study plan

96-hour off IBP wireless pH monitoring capsule

Device

The endoscopic pH measurement capsule will be placed 6cm above the squamocolumnar junction, determined endoscopically, in the sedated patient. Then the plot will be read.

Primary outcomes

  1. GERD Proportion

    Time frame: june 2021-june 2023

    estimate the proportion of GERD measured by wireless pH monitoring capsule in patients in the gray area

  2. Therapeutic response

    Time frame: june 2021-june 2023

    To compare the GERDq scale before and after treatment with proton pump inhibitors.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas José de San Martín

Other

Registry information

Official study title

Usefulness of Wireless pH Monitoring in the Diagnosis of Gastroesophageal Reflux Disease

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.