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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05634187

Acronym

ENTGI-reflux

Enrollment

190

Registered

2022-12-02

Start date

2022-11-20

Completion date

2024-01-23

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux Disease, Reflux, Gastroesophageal, Reflux, Laryngopharyngeal

Keywords

functional endoscopy

Brief summary

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.

Detailed description

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.

Interventions

DEVICEFunctional endoscopy

Transnasal endoscopy by an ultrathin video endoscope

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Endoscopic findings in the laryngeal and pharyngeal area due to reflux	30 minutes	Assessment of endoscopic findings in the laryngeal and pharyngeal area
Endoscopic findings in the oesophagus due to reflux	30 minutes	Assessment of endoscopic findings in the oesophagus

Secondary

Measure	Time frame	Description
Safety of procedure	30 minutes	Assessments of complications

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026