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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05634187
Other study ID # Endoscopy_ENT-GI-Reflux
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2022
Est. completion date January 23, 2024

Study information

Verified date January 2024
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date January 23, 2024
Est. primary completion date January 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Functional endoscopy
Transnasal endoscopy by an ultrathin video endoscope

Locations

Country Name City State
Germany University of Muenster Münster NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Cheung J, Bailey R, Veldhuyzen van Zanten S, McLean R, Fedorak RN, Morse J, Millan M, Guzowski T, Goodman KJ; CANHelp working group. Early experience with unsedated ultrathin 4.9 mm transnasal gastroscopy: a pilot study. Can J Gastroenterol. 2008 Nov;22(1 — View Citation

Herrmann IF, Gadebusch Bondio M, Domagk D, Strahl M, Arens C. [New possibilities with retroflexed functional endoscopy]. HNO. 2018 Jul;66(7):527-533. doi: 10.1007/s00106-018-0518-1. German. — View Citation

Herrmann IF, Scarpignato C. [Functional endoscopy : the physiological and pathophysiological basis of reflux disease, diagnosis and therapy]. HNO. 2009 Dec;57(12):1221-36. doi: 10.1007/s00106-009-1934-z. German. — View Citation

Ruckert J, Lenz P, Heinzow H, Wessling J, Warnecke T, Herrmann IF, Strahl M, Lenze F, Nowacki T, Domagk D. Functional endoscopy in neurogenic dysphagia: a feasibility study focusing on the esophageal phase of swallowing. Endosc Int Open. 2021 Apr;9(4):E64 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Endoscopic findings in the laryngeal and pharyngeal area due to reflux Assessment of endoscopic findings in the laryngeal and pharyngeal area 30 minutes
Primary Endoscopic findings in the oesophagus due to reflux Assessment of endoscopic findings in the oesophagus 30 minutes
Secondary Safety of procedure Assessments of complications 30 minutes
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