Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-11 @ 12:28 PM
Study NCT ID:
NCT02119403
Status:
UNKNOWN
Last Update Posted:
2014-04-21
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Held Nitrous Oxide Delivery Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-17', 'studyFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.', 'timeFrame': 'The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.', 'description': 'This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Minimal Sedation nitrous oxide'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.', 'detailedDescription': 'This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time.\n\nThe device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient undergoing a painful office procedure or exam\n\nExclusion Criteria:\n\n* Women that are Pregnant\n* Children under three years of age'}, 'identificationModule': {'nctId': 'NCT02119403', 'acronym': 'HHN', 'briefTitle': 'Hand Held Nitrous Oxide Delivery Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Strata Medical Innovations'}, 'officialTitle': 'Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.', 'orgStudyIdInfo': {'id': 'smi7531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand Held NitrousTM', 'description': 'There are no other interventions to this device', 'interventionNames': ['Other: There are no other inteventions.']}], 'interventions': [{'name': 'There are no other inteventions.', 'type': 'OTHER', 'description': 'This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation.', 'armGroupLabels': ['Hand Held NitrousTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79423', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Howard Beck', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lubbock Urology', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '79423', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Aldana', 'role': 'CONTACT', 'phone': '806-787-0756'}], 'facility': 'Other Medical Practices', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'centralContacts': [{'name': 'Mark W Aldana, B.S. MBA', 'role': 'CONTACT', 'phone': '806-787-0756'}], 'overallOfficials': [{'name': 'Howard Beck, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Strata Medical Innovations', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Mark Aldana', 'investigatorAffiliation': 'Strata Medical Innovations'}}}}