In-Office Clinical Study of the Solo+ TTD

Otitis Media Clinical Trial

— VENTY  

Official title:

Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741333
• Other study ID #: CSP003
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: AventaMed DAC
• Contact: Keith Jansen
• Phone: +353 21 492 8980
• Email: clinical[@]aventamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 13 Years

Eligibility

Inclusion Criteria:

• Patients aged =6 months to <13 years

• Planned tympanostomy tube insertion

• Patient is able to commit to the follow-up visits and assessments

Exclusion Criteria:

• Anatomy that precludes sufficient visualization of the tympanic membrane

• Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD

• Narrow ear canals

• Congenital or craniofacial abnormalities affecting the ear

• No baseline audiometry or tympanometry

• Familial history of insensitivity to anesthetic components

• Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Related Conditions & MeSH terms

• Ear Infection
• Otitis
• Otitis Media

Intervention

Device:
• Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.

Locations

Country	Name	City	State
United States	Specialty Physician Associates	Bethlehem	Pennsylvania
United States	South Carolina ENT	Columbia	South Carolina
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Sacramento ENT	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
AventaMed DAC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears	Intra-operative
Primary	Rate of Adverse Events	Incidence and nature of device- or procedure-related adverse events	24 months