Trials / Active Not Recruiting
Active Not RecruitingNCT05741333
In-Office Clinical Study of the Solo+ TTD
Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- AventaMed DAC · Industry
- Sex
- All
- Age
- 6 Months – 13 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Detailed description
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \<13 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solo+ Tympanostomy Tube Device (Solo+ TTD) | The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient. |
Timeline
- Start date
- 2023-03-30
- Primary completion
- 2026-05-01
- Completion
- 2028-03-01
- First posted
- 2023-02-23
- Last updated
- 2026-04-01
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05741333. Inclusion in this directory is not an endorsement.