In-Office Clinical Study of the Solo+ TTD

Not Applicable

Recruiting

• Conditions: Otitis Media; Ear Infection
• Interventions: Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)

• Registration Number: NCT05741333
• Lead Sponsor: AventaMed DAC

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solo+ Tympanostomy Tube Device (Solo+ TTD)	Solo+ Tympanostomy Tube Device (Solo+ TTD)	The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.

Primary Outcome Measures

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

Trial Locations

Locations (7)

Southern Head & Neck Surgery; 🇺🇸 Alexander City, Alabama, United States

North Alabama ENT; 🇺🇸 Huntsville, Alabama, United States

East Alabama ENT; 🇺🇸 Opelika, Alabama, United States

Sacramento ENT; 🇺🇸 Sacramento, California, United States

Advanced ENT & Allergy; 🇺🇸 Louisville, Kentucky, United States

Specialty Physician Associates; 🇺🇸 Bethlehem, Pennsylvania, United States

South Carolina ENT; 🇺🇸 Columbia, South Carolina, United States