Imaging of the Auditory tube

Novel Imaging of the Eustachian Tube, a CT study using dilute iodixanol in an adult population

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003614-87-NO

Enrollment

Registered

2015-02-11

Start date

2015-03-27

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis media With effusion

Interventions

Trade Name: Visipaque Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patient > 18 years -reffered to ENT clinic at our hospital for evaluation and treatment of OME, tympanic membrane perforation, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -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 -anatomical variations in the temporal bone or scull base that contraindicates balloon dilation -females who are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To diagnose dysfunction in the eustachian tube by injecting an iodine based contrast medium into the middle ear followed by CT imaging;Secondary Objective: Safety assessments;Primary end point(s): Clinical sucsess after balloon dialtion;Timepoint(s) of evaluation of this end point: Three and six months after contrast medium injection and balloon dilation	—

Secondary

Measure	Time frame
Secondary end point(s): To visualise contrast medium in the epipharyngeal Space or if not obstruction level. Clinical signs of tympanic inflammation Quality of life assessment;Timepoint(s) of evaluation of this end point: 10 minutes after contrast medium injection Three and six months after balloon dilation	—

Countries

Norway

Contacts

Public ContactDep. of Radiology and Nuclear Med.

Oslo University Hospital, Rikshospitalet

ehopp@ous-hf.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026