AERA Pediatrics Registry | NCT07071298

Studies
AERA Pediatrics Registry

NCT07071298

Sponsor

Integra LifeSciences Corporation

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Dysfunction of Eustachian Tube

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2025Actual

Primary Completion Date

Oct 2030Estimated

Completion Date

Feb 2031Estimated

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 8, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

27 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Tympanogram assessed by ear	Tympanogram	27 months
Pure tone audiometry (PTA) assessed by ear	Pure tone audiometry (PTA)	27 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

ETBD with device other than AERA®
Previous ETBD procedure-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ashley Ellis	Contact	17817248422		ashley.ellis@integralife.com

Overall Officials

Name	Affiliation	Role
Christopher Schutt, MD	Acclarent, an Integra LifeSciences Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided