NCT02119403

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

April 11, 2014

Last Update Submit

April 17, 2014

Conditions

Anesthesia

Keywords

Minimal Sedation nitrous oxide

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Hand Held NitrousTM

EXPERIMENTAL

There are no other interventions to this device

Other: There are no other inteventions.

Interventions

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.

Hand Held NitrousTM

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing a painful office procedure or exam

You may not qualify if:

  • Women that are Pregnant
  • Children under three years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lubbock Urology

Lubbock, Texas, 79423, United States

RECRUITING

Other Medical Practices

Lubbock, Texas, 79423, United States

RECRUITING

Study Officials

  • Howard Beck, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark W Aldana, B.S. MBA

CONTACT

806-787-0756

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 21, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

US(2)