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Clinical Trials/NCT07071298
NCT07071298RecruitingNot Applicable

A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System

Integra LifeSciences Corporation10 sites in 1 country300 target enrollmentStarted: June 17, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
10
Primary Endpoint
Failure-free after ETBD with the AERA® device.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Specific indications for ETBD are documented
  • •ETBD with AERA device attempted-

Exclusion Criteria

  • •ETBD with device other than AERA®
  • •Previous ETBD procedure-

Outcomes

Primary Outcomes

Failure-free after ETBD with the AERA® device.

Time Frame: 27 months

Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).

Secondary Outcomes

  • Valsalva maneuver assessed by ear(27 months)
  • Inflammation score assessed by ear(27 months)
  • Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient(27 months)
  • Otitis Media- 6 Questionnaire (OM-6) assessed by patient(27 months)
  • Tympanogram assessed by ear(27 months)
  • Pure tone audiometry (PTA) assessed by ear(27 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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