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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

Stanford University
Palo Alto 5380748, California 5332921 94304
Contact:
Andrea Miranda
andream7@stanford.edu

Michigan Pediatric ENT Associates
West Bloomfield 7259621, Michigan 5001836 48322
Contact:
Amanda West
248-270-6059
amandaw@mpenta.org

Children's Minnesota
Minneapolis 5037649, Minnesota 5037779 55404
Contact:
Stacey Rabusch
651-253-6724
Stacey.Rabusch@childrensmn.org

Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Ashley Williams
Williamsab@chop.edu

Ear and Sinus Institute
Fort Worth 4691930, Texas 4736286 76104
Contact:
Karyn Willyerd
682-718-1778
kwillyerd@berksonmedical.com

More Details

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.