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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, California 94304
Contact:
Andrea Miranda
andream7@stanford.edu

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Brynn Lopez
617-355-6134
brynn.lopez@childrens.harvard.edu

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

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

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Contact:
Katie Sawvell
513-636-4383
Katie.Sawvell@cchmc.org

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

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

Texas Children's Hospital
Houston, Texas 77401
Contact:
Sadaf Batla
Sadaf.Batla@bcm.edu

University of Utah
Salt Lake City, Utah 84113
Contact:
Sarah Al Nemer
u1115482@utah.edu

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.