Anesthetizing the Tympanic Membrane in Healthy Volunteers

Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers

The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.

Study Overview

• Status: Completed
• Conditions: Evaluate Performance and Reliability of Iontophoresis System
• Intervention / Treatment: Device: Acclarent Iontophoresis System

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • East Palo Alto, California, United States, 94303

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. >=18 years of age
2. Both male and female subjects are eligible.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iontophoresis-treated; Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.	Device: Acclarent Iontophoresis System; Administration of local anesthesia using the Acclarent Iontophoresis System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers	X days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse effects associated with the System and the Iontophoresis procedure	The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device.	X days
Tolerability of the iontophoresis system	Subject tolerability of the iontophoresis procedure will be assessed using a pain scale	X days

Collaborators and Investigators

• Sponsor: Acclarent

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: January 11, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CPR005006