Trials / Unknown
UnknownNCT03722160
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 post-approval evaluation of 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 TympanostomyTube 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
- 2018-09-13
- Primary completion
- 2019-11-01
- Completion
- 2019-11-01
- First posted
- 2018-10-26
- Last updated
- 2019-10-28
Locations
3 sites across 2 countries: Italy, United Kingdom
Source: ClinicalTrials.gov record NCT03722160. Inclusion in this directory is not an endorsement.