RECRUITING

AERA Pediatrics Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System

Quick Facts

Study Start:2025-06-17
Study Completion:2031-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07071298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \<18
  2. 2. Specific indications for ETBD are documented
  3. 3. ETBD with AERA device attempted-
  1. 1. ETBD with device other than AERA®
  2. 2. Previous ETBD procedure-

Contacts and Locations

Study Contact

Ashley Ellis
CONTACT
17817248422
ashley.ellis@integralife.com

Principal Investigator

Christopher Schutt, MD
STUDY_DIRECTOR
Acclarent, an Integra LifeSciences Company

Study Locations (Sites)

Michigan Pediatric ENT Associates
West Bloomfield, Michigan, 48322
United States
Ear and Sinus Institute
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Integra LifeSciences Corporation

  • Christopher Schutt, MD, STUDY_DIRECTOR, Acclarent, an Integra LifeSciences Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17
Study Completion Date2031-02

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2031-02

Terms related to this study

Keywords Provided by Researchers

  • ETBD

Additional Relevant MeSH Terms

  • Dysfunction of Eustachian Tube