Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 6:15 AM
Study NCT ID:
NCT01346332
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2011-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2011-04-29', 'studyFirstSubmitQcDate': '2011-05-02', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores on visual analog scale', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia of Tympanic Membrane']}, 'descriptionModule': {'briefSummary': 'The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 2 years old\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* 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\n* Significant atrophic or perforated tympanic membrane\n* Otitis externa\n* Damaged or denuded skin in the auditory canal\n* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)\n* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane\n* Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure'}, 'identificationModule': {'nctId': 'NCT01346332', 'acronym': 'IPSHS', 'briefTitle': 'Healthy Volunteer Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Performance of the Iontophoresis System With Headset in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CPR005021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anesthetization', 'interventionNames': ['Device: Iontophoresis System with Headset']}], 'interventions': [{'name': 'Iontophoresis System with Headset', 'type': 'DEVICE', 'description': 'Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset', 'armGroupLabels': ['Anesthetization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'East Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'CEI Medical Group', 'geoPoint': {'lat': 37.46883, 'lon': -122.14108}}], 'overallOfficials': [{'name': 'Joseph Roberson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEI Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}