Usefulness of Wireless pH Monitoring in GERD Diagnosis

NCT05452603 | Completed FDA Device

• 1 other identifier: 27251302710
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux

Keywords

gastroesophageal reflux disease; gray area; wireless pH monitoring

Outcome Measures

Primary Outcomes (2)

• GERD Proportion

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

  june 2021-june 2023

• Therapeutic response

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

  june 2021-june 2023

Study Arms (1)

Study group

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

Device: 96-hour off IBP wireless pH monitoring capsule

Interventions

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.

Study group

Eligibility Criteria

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

Study Population

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. .

You may qualify if:

• 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. .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead

Study Sites (1)

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, B1622, Argentina

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 11, 2022
• Study Start: June 20, 2021
• Primary Completion: June 20, 2024
• Study Completion: July 20, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

AR (1)