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Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus (IONTO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acclarent.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT00941993
First received: July 14, 2009
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for local anesthetic procedures requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.


Condition Intervention
Acute Otitis Media
Chronic Otitis Media
Recurrent Acute Otitis Media
 Device: Iontophoresis System (Acclarent)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Evaluate the anesthetic effect of the Acclarent designed iontophoresis local anesthesia system. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate patient tolerability of the bilateral iontophoresis procedure. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Evaluate parent satisfaction with the in-office procedure. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Evaluate any adverse effects associated with the iontophoresis system. [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anesthesia
tympanic membrane anesthesia delivery system
 Device: Iontophoresis System (Acclarent)
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
Other Name: Acclarent

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12 months and older
  2. Both male and female patients eligible
  3. Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)

Exclusion Criteria:

  1. Patients 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
  2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
  3. Otitis externa
  4. Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
  5. Damaged or denuded skin in the auditory canal
  6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941993

Locations
United States, Georgia
Xxx
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: xx xx xxx
  More Information

No publications provided

Responsible Party: Patricia Chen, Sr. CRA, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT00941993     History of Changes
Other Study ID Numbers: CPR005000
Study First Received: July 14, 2009
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Epinephrine
Epinephryl borate
Lidocaine
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on May 19, 2013