NCT05634187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

April 15, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

November 21, 2022

Last Update Submit

April 12, 2024

Conditions

Reflux DiseaseReflux, GastroesophagealReflux, Laryngopharyngeal

Keywords

functional endoscopy

Outcome Measures

Primary Outcomes (2)

  • Endoscopic findings in the laryngeal and pharyngeal area due to reflux

    Assessment of endoscopic findings in the laryngeal and pharyngeal area

    30 minutes

  • Endoscopic findings in the oesophagus due to reflux

    Assessment of endoscopic findings in the oesophagus

    30 minutes

Secondary Outcomes (1)

  • Safety of procedure

    30 minutes

Study Arms (1)

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

Interventions

Functional endoscopyDEVICE

Transnasal endoscopy by an ultrathin video endoscope

Patients suffering from symptoms suggestive for gastroesophageal reflux disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Inability to understand information for participation
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related 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(11):917-22. doi: 10.1155/2008/323027.

    PMID: 19018337RESULT

  • 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.

    PMID: 19924362RESULT

  • 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.

    PMID: 29968191RESULT

  • 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.

    PMID: 33880400RESULT

MeSH Terms

Conditions

Gastroesophageal RefluxLaryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract Diseases

Study Officials

  • Dirk Domagk, MD

    Josephs Hospital Warendorf, Academic Teaching Hospital University of Muenster

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 2, 2022

Study Start

November 20, 2022

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

April 15, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)