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The Diagnostics of Extraesophageal Reflux With the Restech System

NCT01819454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-09-08

No results posted yet for this study

Summary

The aim of the project is to define the frequency with which EER is present in patient with chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring of the pH using the Restech system. This modern device is equipped with a narrow antimony probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The second aim is to determine the relation among EER, CHR and asthma bronchiale. We will compare the presence of reflux in three different patient groups (1. CHR without nasal polyposis, without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without asthma bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or ASA syndrome). We expect to find a significantly more frequent presence of EER in patients with CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will be especially these patients(with a difficult to manage nasal polyposis) benefiting from the antireflux therapy.

Conditions

  • Nasal Diseases
  • Nasal Polyps
  • Laryngopharyngeal Reflux

Interventions

DEVICE

pH monitoring (Restech)

see in "detail description of the study" part of the protocol

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Karol Zelenik, MD,PhD · University Hospital Ostrava

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Czechia

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 NCT01819454 on ClinicalTrials.gov