Trials / Unknown
UnknownNCT03633942
Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position
Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Laser Spine Institute · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use.
Detailed description
This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use. During surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the LMA Supreme laryngeal mask airway.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LMA Supreme | Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position. |
Timeline
- Start date
- 2018-07-27
- Primary completion
- 2019-07-27
- Completion
- 2020-07-27
- First posted
- 2018-08-16
- Last updated
- 2018-08-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03633942. Inclusion in this directory is not an endorsement.