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 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