AnesthesiaHHNNCT02119403
Hand Held Nitrous Oxide Delivery Device
A study testing There are no other inteventions. in people with Anesthesia, run by Strata Medical Innovations at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- There are no other inteventions.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient undergoing a painful office procedure or exam
Who cannot join
- Women that are Pregnant
- Children under three years of age
Trial locations and contacts
2 sites in 1 country.
Mark W Aldana, B.S. MBA contact
United States2 sites, 2 recruiting
- Recruiting
Lubbock Urology
Lubbock, Texas, 79423
Howard Beck
- Recruiting
Other Medical Practices
Lubbock, Texas, 79423
Mark Aldana, 806-787-0756
About this study
Official title: Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.
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.
Read the detailed description
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.
- Conditions
- Anesthesia
- Being tested
- There are no other inteventions.
- Keywords
- Minimal Sedation nitrous oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hand Held NitrousTM | Experimental | There are no other interventions to this device Receives: Other: There are no other inteventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Strata Medical Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mark Aldana, Strata Medical Innovations
- Investigators
- Howard Beck, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119403
- Sponsor's protocol ID
- smi7531
- Acronym
- HHN
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.
- ClinicalTrials.gov ID
- NCT02119403
- Acronym / sponsor ID
- HHN / smi7531
- Conditions
- Anesthesia
- Keywords
- Minimal Sedation nitrous oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Strata Medical InnovationsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand Held NitrousTM | Experimental | Other: There are no other inteventions.There are no other interventions to this device |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing a painful office procedure or exam
Key exclusion criteria (2 listed)
- Women that are Pregnant
- Children under three years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Hand Held NitrousTM |
Primary outcome
This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.
Time frame: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.
This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Aldana, B.S. MBA contact
Howard Beck, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing There are no other inteventions. in people with Anesthesia, run by Strata Medical Innovations at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark W Aldana, B.S. MBA (806-787-0756), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide. (time frame: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.