- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634187
One-stop-shop Endoscopy in Reflux-patients: Evaluation of ENT and GI Features (ENTGI-reflux)
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Dirk Domagk, MD
- Phone Number: 00492581201401
- Email: domagkd@uni-muenster.de
Study Contact Backup
- Name: Philipp Lenz, MD
- Phone Number: 00492518353052
- Email: lenzph@uni-muenster.de
Study Locations
-
-
NRW
-
Münster, NRW, Germany, 48149
- University of Muenster
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients suffering from symptoms suggestive for gastroesophageal reflux disease
Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease
|
Transnasal endoscopy by an ultrathin video endoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
Endoscopic findings in the oesophagus due to reflux
Time Frame: 30 minutes
|
Assessment of endoscopic findings in the oesophagus
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of procedure
Time Frame: 30 minutes
|
Assessments of complications
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dirk Domagk, MD, Josephs Hospital Warendorf, Academic Teaching Hospital University of Muenster
Publications and helpful links
General Publications
- 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(11):917-22. doi: 10.1155/2008/323027.
- 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.
- 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):E646-E652. doi: 10.1055/a-1380-3224. Epub 2021 Apr 15.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endoscopy_ENT-GI-Reflux
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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