Reflux, Gastroesophageal Clinical Trial
— ENTGI-refluxOfficial 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
Verified date | January 2024 |
Source | University Hospital Muenster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Muenster | Münster | NRW |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
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
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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