In-Office Clinical Study of the Solo+ TTD
VENTY
Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
1 other identifier
interventional
66
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedApril 1, 2026
March 1, 2026
3.1 years
February 14, 2023
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Procedure Success
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Intra-operative
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
24 months
Study Arms (1)
Solo+ Tympanostomy Tube Device (Solo+ TTD)
EXPERIMENTALThe 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.
Interventions
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Eligibility Criteria
You may qualify if:
- Patients aged ≥6 months to \<13 years
- Planned tympanostomy tube insertion
- Patient is able to commit to the follow-up visits and assessments
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AventaMed DAClead
Study Sites (7)
Southern Head & Neck Surgery
Alexander City, Alabama, 35010, United States
North Alabama ENT
Huntsville, Alabama, 35801, United States
East Alabama ENT
Opelika, Alabama, 36801, United States
Sacramento ENT
Sacramento, California, 95661, United States
Advanced ENT & Allergy
Louisville, Kentucky, 40220, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017, United States
South Carolina ENT
Columbia, South Carolina, 29203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Matija Daniel
Queen's Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
February 23, 2023
Study Start
March 30, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
March 1, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share