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

Sponsor

University Hospital Muenster (Other)

Overall Status

Recruiting

CT.gov ID

NCT05634187

Collaborator

(none)

100

Enrollment

Location

9.3

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reflux Disease Reflux, Gastroesophageal Reflux, Laryngopharyngeal	Device: Functional endoscopy

Detailed Description

Patients suffering from gastroesopheal 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Simulanteous Evaluation of Endoscopic Features in Patients Suffering From Gastroesophageal Reflux: Functional Endoscopy Gives Insight for ENT and GI Alterations - a Prospective Study

Actual Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients suffering from symptoms suggestive for gastroesophageal reflux disease Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease	Device: Functional endoscopy Transnasal endoscopy by an ultrathin video endoscope

Arm

Intervention/Treatment

Patients suffering from symptoms suggestive for gastroesophageal reflux disease

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

Device: Functional endoscopy

Transnasal endoscopy by an ultrathin video endoscope

Outcome Measures

Primary Outcome Measures

Endocopic findings in the laryngeal and pharyngeal area due to reflux [30 minutes]
Assessment of endocopic findings in the laryngeal and pharyngeal area
Endocopic findings in the oesophagus due to reflux [30 minutes]
Assessment of endocopic findings in the oesophagus

Secondary Outcome Measures

Safety of procedure [30 minutes]
Assessments of complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Muenster	Münster	NRW	Germany	48149

Sponsors and Collaborators

University Hospital Muenster

Investigators

Study Chair: Dirk Domagk, MD, Josephs Hospital Warendorf, Academic Teaching Hospital University of Muenster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Muenster

ClinicalTrials.gov Identifier:

NCT05634187

Other Study ID Numbers:

Endoscopy_ENT-GI-Reflux

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 6, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Muenster

functional endoscopy

Additional relevant MeSH terms:

Gastroesophageal Reflux

Laryngopharyngeal Reflux

Study Results

No Results Posted as of Dec 6, 2022