NCT01047904

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

January 11, 2010

Last Update Submit

July 10, 2024

Conditions

Evaluate Performance and Reliability of Iontophoresis System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of adverse effects associated with the System and the Iontophoresis procedure

    X days

  • Tolerability of the iontophoresis system

    X days

Study Arms (1)

Iontophoresis-treated

EXPERIMENTAL

Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.

Device: Acclarent Iontophoresis System

Interventions

Acclarent Iontophoresis SystemDEVICE

Administration of local anesthesia using the Acclarent Iontophoresis System

Iontophoresis-treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=18 years of age
  • Both male and female subjects are eligible.

You may not qualify if:

  • Pregnant or lactating females
  • 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.
  • Markedly atrophic TM
  • Perforated TM
  • Sclerotic TM
  • Otitis externa
  • Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
  • Damaged or denuded skin in the auditory canal
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

East Palo Alto, California, 94303, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 13, 2010

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

US(1)