NCT01611246

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

May 29, 2012

Last Update Submit

July 10, 2024

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

  • Number of subjects anesthetized as assessed by Wong-Baker scale

    Day 1

Secondary Outcomes (1)

  • Number of participants with serious adverse events

    Day 1

Study Arms (1)

Anesthetization

Anesthetization

Device: Iontophoresis System With Earset

Interventions

Iontophoresis System With EarsetDEVICE

iontophoresis of lidocaine-based solution for numbing tympanic membrane

Anesthetization

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 months old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEI Medical Group

East Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Joseph Roberson, M.D.

    CEI Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 4, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

US(1)