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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Held NitrousTM | Experimental | There are no other interventions to this device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There are no other inteventions. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide. | This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes). | The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark W Aldana, B.S. MBA | Contact | 806-787-0756 |
| Name | Affiliation | Role |
|---|---|---|
| Howard Beck, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lubbock Urology | Recruiting | Lubbock | Texas | 79423 | United States |
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| Other Medical Practices | Recruiting | Lubbock | Texas | 79423 | United States |
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