Usefulness of Wireless pH Monitoring in GERD Diagnosis

Sponsor
Hospital de Clinicas José de San Martín (Other)
Overall Status
Recruiting
CT.gov ID
NCT05452603
Collaborator
(none)
30
1
25
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 96-hour off IBP wireless pH monitoring capsule

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Usefulness of Wireless pH Monitoring in the Diagnosis of Gastroesophageal Reflux Disease
Actual Study Start Date :
Jun 20, 2021
Anticipated Primary Completion Date :
Jun 20, 2023
Anticipated Study Completion Date :
Jul 20, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. GERD Proportion [june 2021-june 2023]

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

  2. Therapeutic response [june 2021-june 2023]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Clinicas Jose de San Martin. Buenos Aires University Buenos Aires Argentina B1622

Sponsors and Collaborators

  • Hospital de Clinicas José de San Martín

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Marta Piskorz, Principal investigator, Hospital de Clinicas José de San Martín
ClinicalTrials.gov Identifier:
NCT05452603
Other Study ID Numbers:
  • 27251302710
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Maria Marta Piskorz, Principal investigator, Hospital de Clinicas José de San Martín
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022