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Purpose

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

Condition

Eligibility

Eligible Ages
Under 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age <18 2. Specific indications for ETBD are documented 3. ETBD with AERA device attempted-

Exclusion Criteria

  1. ETBD with device other than AERA® 2. Previous ETBD procedure-

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

Michigan Pediatric ENT Associates
West Bloomfield, Michigan 48322
Contact:
Amanda West
248-270-6059
amandaw@mpenta.org

More Details

NCT ID
NCT07071298
Status
Recruiting
Sponsor
Integra LifeSciences Corporation

Study Contact

Ashley Ellis
17817248422
ashley.ellis@integralife.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center