Recruiting

AERA® Device

Sponsor:

Integra LifeSciences Corporation

Code:

NCT07071298

Conditions

Dysfunction of Eustachian Tube

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Dysfunction of Eustachian Tube

Study ID

NCT07071298

Start date

Jun 17, 2025

Status verified date

Jul, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Failure-free after ETBD with the AERA® device. [ Time Frame: 27 months ]

Central Contacts and Locations

Central contacts

Ashley Ellis

17817248422ashley.ellis@integralife.com

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Andrea Miranda

andream7@stanford.edu

Principal Investigator:

Kay Chang

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Brynn Lopez

617-355-6134brynn.lopez@childrens.harvard.edu

Principal Investigator:

Dennis Poe

Michigan Pediatric ENT Associates

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Amanda West

248-270-6059amandaw@mpenta.org

Principal Investigator:

Prasad Thottam, DO, FAAP

Children's Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Stacey Rabusch

651-253-6724Stacey.Rabusch@childrensmn.org

Principal Investigator:

Asitha Jayawardena, MD, MPH

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Katie Sawvell

513-636-4383Katie.Sawvell@cchmc.org

Principal Investigator:

Michael DeMarcantonio

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ashley Williams

Williamsab@chop.edu

Principal Investigator:

Ken Kazahaya

Ear and Sinus Institute

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Karyn Willyerd

682-718-1778kwillyerd@berksonmedical.com

Principal Investigator:

Marc Dean, M.D.

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77401

Contacts

Sadaf Batla

Sadaf.Batla@bcm.edu

Principal Investigator:

Yi-Chun Liu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Sarah Al Nemer

u1115482@utah.edu

Principal Investigator:

Albert Park, MD

More Information

Sponsor

Integra LifeSciences Corporation

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • ETBD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Integra LifeSciences Corporation on 2026-07-07.