Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

NCT07029997 | Not Yet Recruiting

• 1 other identifier: CSP004
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

Conditions

Otitis Media; Middle Ear Infections

Keywords

ear tubes

Outcome Measures

Primary Outcomes (3)

• Procedure Success (Performance)

  Percentage of subjects in which the tympanostomy tube is inserted in all indicated ears in a single procedure without the need to schedule a secondary procedure

  48 months

• Functioning Tubes (Performance)

  Percentage of ears with a functioning tube (without extrusion and without occlusion) at standard of care follow-up visits until tube extrusion or discharge from standard clinical care

  48 months

• Early Adverse Event (AE) Rates (Safety)

  Incidence and nature of device- or procedure-related AEs (per ear and per subject) from the day of the procedure to first follow-up visit post procedure

  48 months

Study Arms (1)

adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective.

Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)

Interventions

Solo+ Tympanostomy Tube Device (Solo+ TTD) DEVICE

insertion of eartubes

adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult and paediatric patients (over 6 months) requiring tympanostomy tube placement treated with Solo+ TTD. It is anticipated at least 75% of the study population will be comprised of paediatric patients (under 18 years of age)

You may qualify if:

• Subject and/or Parent/Guardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent
• Subject was or will be treated, or had a treatment attempted with the study device.

You may not qualify if:

• None

Sponsors & Collaborators

• AventaMed DAC: lead

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 19, 2025

Record last verified: 2025-06