Trials / Unknown
UnknownNCT04148417
Clinical Study of the Solo+ Tympanostomy Tube Device
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- AventaMed DAC · Industry
- Sex
- All
- Age
- 6 Months – 15 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
Detailed description
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solo+ Tympanostomy Tube Device | The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure |
Timeline
- Start date
- 2021-02-09
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
- First posted
- 2019-11-01
- Last updated
- 2024-01-24
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04148417. Inclusion in this directory is not an endorsement.