Trials / Completed
CompletedNCT03503591
Study of the Hummingbird TTS™ Tympanostomy Tube System
Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 109 (actual)
- Sponsor
- Preceptis Medical, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
Detailed description
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hummingbird Tympanostomy Tube System | Insertion of a ventilation tube under sedation and local anesthetic |
Timeline
- Start date
- 2016-01-29
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2018-04-20
- Last updated
- 2022-11-21
- Results posted
- 2022-11-21
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03503591. Inclusion in this directory is not an endorsement.