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Clinical Trials/EUCTR2014-003614-87-NO
EUCTR2014-003614-87-NO
Active, not recruiting
Phase 1

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

Oslo University Hospital0 sites23 target enrollmentFebruary 11, 2015
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ConditionsOtitis media With effusionTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
DrugsVisipaque

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Otitis media With effusion
Sponsor
Oslo University Hospital
Enrollment
23
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 11, 2015
End Date
June 30, 2017
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Oslo University Hospital

Eligibility 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

  • •\-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

Outcomes

Primary Outcomes

Not specified

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