NCT07071298

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2025Feb 2031

Study Start

First participant enrolled

June 17, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5.3 years

First QC Date

July 8, 2025

Last Update Submit

December 29, 2025

Conditions

Dysfunction of Eustachian Tube

Keywords

ETBD

Outcome Measures

Primary Outcomes (1)

  • Failure-free after ETBD with the AERA® device.

    Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).

    27 months

Secondary Outcomes (6)

  • Tympanogram assessed by ear

    27 months

  • Pure tone audiometry (PTA) assessed by ear

    27 months

  • Valsalva maneuver assessed by ear

    27 months

  • Inflammation score assessed by ear

    27 months

  • Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient

    27 months

  • +1 more secondary outcomes

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects under the age of 18 with ETD who are treated with the AERA® device

You may qualify if:

  • Age \<18
  • Specific indications for ETBD are documented
  • ETBD with AERA device attempted-

You may not qualify if:

  • ETBD with device other than AERA®
  • Previous ETBD procedure-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Michigan Pediatric ENT Associates

West Bloomfield, Michigan, 48322, United States

RECRUITING

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Ear and Sinus Institute

Fort Worth, Texas, 76104, United States

RECRUITING

Study Officials

  • Christopher Schutt, MD

    Acclarent, an Integra LifeSciences Company

    STUDY DIRECTOR

Central Study Contacts

Ashley Ellis

CONTACT

17817248422ashley.ellis@integralife.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
27 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

February 1, 2031

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

US(6)