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Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care

NCT03766568 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-14

No results posted yet for this study

Summary

This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples from the middle meatus of the sinus. The JGG endoscope® is sterile packaged, for one way use and disposable.

Conditions

  • Acute Bacterial Sinusitis

Interventions

DEVICE

JGG endoscope(R)

The JGG endoscope(R) is attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Dominik Glinz

    lead OTHER

Principal Investigators

  • Heiner C Bucher, Prof. · CEB

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2020-05-31
Completion
2020-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766568 on ClinicalTrials.gov