Back to resultsIn-Office Clinical Study of the Solo+ TTD (VENTY)
Primary Purpose
Ear Infection, Otitis Media
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Solo+ Tympanostomy Tube Device (Solo+ TTD)
Sponsored by
About this trial
This is an interventional treatment trial for Ear Infection
Eligibility Criteria
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
Sites / Locations
- Advanced ENT & AllergyRecruiting
- Specialty Physician AssociatesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solo+ Tympanostomy Tube Device (Solo+ TTD)
Arm Description
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.
Outcomes
Primary Outcome Measures
Procedure Success
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05741333
Brief Title
In-Office Clinical Study of the Solo+ TTD
Acronym
VENTY
Official Title
Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AventaMed DAC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Infection, Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solo+ Tympanostomy Tube Device (Solo+ TTD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Solo+ Tympanostomy Tube Device (Solo+ TTD)
Intervention Description
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Primary Outcome Measure Information:
Title
Procedure Success
Description
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Time Frame
Intra-operative
Title
Rate of Adverse Events
Description
Incidence and nature of device- or procedure-related adverse events
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Jansen
Phone
+353 21 492 8980
Email
clinical@aventamed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matija Daniel
Organizational Affiliation
Queen's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Advanced ENT & Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Leonard
Phone
502-893-0159
Email
jleonard@advancedentandallergy.com
Facility Name
Specialty Physician Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Campbell
Phone
610-866-5555
Email
dcampbell@specialtyphysicianassociates.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
In-Office Clinical Study of the Solo+ TTD
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