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OpenTrials
Completed

NCT Number: NCT05634187

One-stop-shop Endoscopy in Reflux-patients: Evaluation of ENT and GI Features

Patients suffering from gastroesophageal reflux may suffer from both esophageal and laryngeal irritations. The investigators developed an endoscopic technique called functional endoscopy to evaluate alterations in the larynx and pharynx as well as in the esophagus simultaneously as one-stop-shop.

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Key information

Conditions

Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngeal Diseases Laryngopharyngeal Reflux Reflux, Gastroesophageal Reflux, Laryngopharyngeal Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Muenster

Münster, North Rhine-Westphalia, 48149, Germany

About this study

Patients suffering from gastroesophageal reflux may present to a variety of medical specialists according to their individual complaints (e.g., heartburn, hoarseness, dysphasia). In general, these addressed specialist may focus their attention to their individual fields of interest.

The investigators developed an endoscopic technique called functional endoscopy to evaluate patients with various GI- or ENT (ear-nose-throat)-symptoms being suggestive for gastroesophageal reflux disease.

In functional endoscopy, unsedated patients are examined with an ultrathin endoscope via the transnasal route. Reflux-associated features in the field of interest of the ENT-doctor and the GI-specialist are recorded and documented in the same session.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease

Exclusion criteria

  • Age under 18 years
  • Inability to understand information for participation
  • Refusal of participation

Treatment and study plan

Functional endoscopy

Device

Transnasal endoscopy by an ultrathin video endoscope

Primary outcomes

  1. Endoscopic findings in the laryngeal and pharyngeal area due to reflux

    Time frame: 30 minutes

    Assessment of endoscopic findings in the laryngeal and pharyngeal area

  2. Endoscopic findings in the oesophagus due to reflux

    Time frame: 30 minutes

    Assessment of endoscopic findings in the oesophagus

Secondary outcomes

  1. Safety of procedure

    Time frame: 30 minutes

    Assessments of complications

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

Simultaneous Evaluation of Endoscopic Features in Patients Suffering From Gastroesophageal Reflux: Functional Endoscopy Gives Insight for ENT (Ear-nose-throat) and GI Alterations - a Prospective Study

Acronym: ENTGI-reflux

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Apr 15, 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.

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