Healthy Volunteer Study | NCT01346332

Studies
Healthy Volunteer Study

NCT01346332

Sponsor

Integra LifeSciences Corporation

Status

Completed

Last Update Posted

Jul 11, 2024Actual

Enrollment

106Actual

Phase

Not provided

Conditions

Anesthesia of Tympanic Membrane

Interventions

Iontophoresis System with Headset

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

Apr 1, 2011Actual

Primary Completion Date

Feb 1, 2012Actual

Completion Date

Feb 1, 2012Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

May 2, 2011

First Posted Date

May 3, 2011Estimated

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 Headset.

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

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anesthetization			Device: Iontophoresis System with Headset

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iontophoresis System with Headset	Device	Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset	Anesthetization

Measure	Description	Time Frame
Pain scores on visual analog scale		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 2 years old

Exclusion Criteria:

Pregnant or lactating females
Subject with a 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
Significant 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

2 Years

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, MD	CEI Medical Group	Principal Investigator

Locations

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