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Usefulness of Wireless pH Monitoring in GERD Diagnosis

NCT05452603 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-10-23

No results posted yet for this study

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

Interventions

DEVICE

96-hour off IBP wireless pH monitoring capsule

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.

Sponsors & Collaborators

  • Hospital de Clinicas José de San Martín

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2024-06-20
Completion
2024-07-20
FDA Device
Yes

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452603 on ClinicalTrials.gov