AERA Pediatrics Registry

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

  • Dysfunction of Eustachian Tube

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