Trials / Completed
CompletedNCT04128527
AuraOnce Performance Observation
Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (actual)
- Sponsor
- Ambu A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark. The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019. The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.
Detailed description
This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark. The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Placement of laryngeal mask | All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice. |
Timeline
- Start date
- 2019-10-09
- Primary completion
- 2019-11-05
- Completion
- 2019-11-05
- First posted
- 2019-10-16
- Last updated
- 2021-11-03
- Results posted
- 2021-11-03
Locations
1 site across 1 country: Denmark
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04128527. Inclusion in this directory is not an endorsement.