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
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2013-07-31
2014-12-31
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Hand Held NitrousTM
There are no other interventions to this device
There are no other inteventions.
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.
Interventions
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There are no other inteventions.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children under three years of age
3 Years
ALL
No
Sponsors
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Strata Medical Innovations
INDUSTRY
Responsible Party
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Mark Aldana
President
Principal Investigators
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Howard Beck, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Lubbock Urology
Lubbock, Texas, United States
Other Medical Practices
Lubbock, Texas, United States
Countries
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Central Contacts
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Mark W Aldana, B.S. MBA
Role: CONTACT
Facility Contacts
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Mark Aldana
Role: primary
Other Identifiers
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smi7531
Identifier Type: -
Identifier Source: org_study_id
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