Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
106 participants
OBSERVATIONAL
2011-04-01
2012-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol
NCT03125824
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
NCT02877667
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
NCT04836572
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology
NCT02426593
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
NCT00001846
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anesthetization
Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
2 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Roberson, MD
Role: PRINCIPAL_INVESTIGATOR
CEI Medical Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CEI Medical Group
East Palo Alto, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CPR005021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.