- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346332
Healthy Volunteer Study (IPSHS)
July 21, 2017 updated by: Acclarent
Performance of the Iontophoresis System With Headset in Healthy Volunteers
The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
East Palo Alto, California, United States, 94303
- CEI Medical Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anesthetization
|
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores on visual analog scale
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Roberson, MD, CEI Medical Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 29, 2011
First Submitted That Met QC Criteria
May 2, 2011
First Posted (Estimate)
May 3, 2011
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
July 21, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CPR005021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia of Tympanic Membrane
-
University Hospital Plymouth NHS TrustWithdrawnEustachian Tube Dysfunction | Retraction of the Pars Tensa of the Tympanic Membrane | Retraction Pocket of the Tympanic MembraneUnited Kingdom
-
Astellas Pharma Global Development, Inc.TerminatedChronic Tympanic Membrane PerforationUnited States
-
Mahidol UniversityUnknownAnesthesia of Mucous MembraneThailand
-
Central Adelaide Local Health Network IncorporatedUniversity of AdelaideRecruitingSurgery | Otitis Media | Tympanic Membrane Perforation | Tympanic Membrane InflammationAustralia
-
University of British ColumbiaCompleted
-
University of MichiganAmerican Association of EndodontistsCompletedAnesthesia of Mucous MembraneUnited States
-
Assiut UniversityUnknownTympanic Membrane Perforation
-
Dr. Bradley WellingUnited States Department of DefenseCompletedTympanic Membrane PerforationUnited States
-
Mohammad Sadegh Bagheri BaghdashtCompletedTympanic Membrane Perforation
-
Assiut UniversityUnknownTympanic Membrane Perforation
Clinical Trials on Iontophoresis System with Headset
-
AppliedVR Inc.Completed
-
Stanford UniversityRecruitingPassive VS Active VR on HPT Using the Thermal Sensory Analyzer With a Peltier-Based Contact ThermodePain | AnxietyUnited States
-
University of OtagooVRcomeCompleted
-
Stanford UniversityRecruitingAnxiety | Parents | Virtual RealityUnited States
-
George Washington UniversityTerminated
-
Medical University of South CarolinaCompleted
-
Stanford UniversityNot yet recruitingAnxiety | Virtual RealityUnited States
-
Sheba Medical CenterRecruitingPatient SatisfactionIsrael
-
University of OtagooVRcomeActive, not recruiting
-
C.R.Darnall Army Medical CenterCompletedProcedural Pain | Procedural AnxietyUnited States