Earset Healthy Volunteer Study | NCT01611246

Studies
Earset Healthy Volunteer Study

NCT01611246

Sponsor

Integra LifeSciences Corporation

Status

Completed

Last Update Posted

Jul 11, 2024Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Otitis Media

Interventions

Iontophoresis System With Earset

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 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2012Actual

Primary Completion Date

Aug 1, 2012Actual

Completion Date

Aug 1, 2012Actual

First Submitted Date

May 29, 2012

First Submission Date that Met QC Criteria

May 31, 2012

First Posted Date

Jun 4, 2012Estimated

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 10, 2024

Last Update Posted Date

Jul 11, 2024Actual

Name	Class
Acclarent	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anesthetization		Anesthetization	Device: Iontophoresis System With Earset

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iontophoresis System With Earset	Device	iontophoresis of lidocaine-based solution for numbing tympanic membrane	Anesthetization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects anesthetized as assessed by Wong-Baker scale		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with serious adverse events		Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 12 months old

Exclusion Criteria:

Pregnant or lactating females
Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
Significantly atrophic or perforated tympanic membrane
Otitis externa
Damaged or denuded skin in the auditory canal
Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Roberson, M.D.	CEI Medical Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEI Medical Group		East Palo Alto	California	94303	United States

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided