RecruitingNot Applicable

AERA Pediatrics Registry

United States300 participantsStarted 2025-06-17

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \<18
✓. Specific indications for ETBD are documented
✓. ETBD with AERA device attempted-

Exclusion criteria

✕. ETBD with device other than AERA®
✕. Previous ETBD procedure-

What they're measuring

Failure-free after ETBD with the AERA® device.

Timeframe: 27 months

Trial details

NCT IDNCT07071298

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-10

Contact for this trial

Ashley Ellis

17817248422 ashley.ellis@integralife.com

View on ClinicalTrials.gov More Dysfunction of Eustachian Tube trials