Novel Imaging of the Eustachian Tube; Patient Study

NCT02282540 | Completed

• 1 other identifier: ET31068
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to establish wether a contrast medium applied to the middle ear can be used to diagnose pathology in the auditory tube. We will examine patients with and without middle ear disease with CT after the application of an iodine based contrast medium.

Conditions

Otitis Media With Effusion; Eustachian Tube Disorder

Outcome Measures

Primary Outcomes (1)

• Extent of contrast medium passage through the Eustachian tube

  CT-imaging to assess contrast enhancement of the ET or pharyngeal space. Either of four alternatives is possible: 1. Contrast enhancement of the pharyngeal space. 2. Contrast enhancement of the ET on the oral side of the isthmus 3. Contrast enhancement of the bony part of the ET, but not passed the isthmus 4. No contrast enhancement of the ET

  10 minutes after contrast medium application

Secondary Outcomes (2)

• Local side effects of contrast medium application

  4 weeks

• Local side effects of contrast medium application

  4 weeks

Study Arms (1)

Iodixanol to the Eustachian tube

EXPERIMENTAL

Iodixanol contrast medium diluted with NaCl to 20% into the tympanostomy tube while the patient lies on his / her back with the head slightly turned to the opposite side. After 10 minutes the CT examination will be conducted using 200 mA and 120 kV.

Procedure: Iodixanol to the Eustachian tube

Interventions

Iodixanol to the Eustachian tube PROCEDURE

Application of iodixanol to the middle ear for imaging of the ET.

Iodixanol to the Eustachian tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old Referred to ENT clinic at Rikshospitalet for evaluation and treatment of OME, tympanic membrane peroration or tympanic membrane retraction Dysfunction of the ET is suspected by the ENT surgeon The patient is a candidate for balloon dilation of the ET

You may not qualify if:

• Previous serious allergic reaction to iodine based contrast medium Increased risk of bleeding Serious heart disease Diabetes I Previous ENT-surgery (t-tubes excluded) Middle ear disease, which requires other type of treatment Chronic rhino sinusitis or nasal polyposis Pregnancy

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo UH

Oslo, 0372, Norway

Location

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jens Petter Berg, MD, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: November 4, 2014
• Study Start: May 1, 2015
• Primary Completion: October 20, 2017
• Study Completion: November 29, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

NO (1)