Back to resultsClinical Study of the Solo+ Tympanostomy Tube Device
Primary Purpose
Ear Infection, Otitis Media
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Solo+ Tympanostomy Tube Device
Sponsored by
About this trial
This is an interventional treatment trial for Ear Infection
Eligibility Criteria
Inclusion Criteria:
- Listed for bilateral tympanostomy tube insertion
Exclusion Criteria:
- Anatomy that precludes sufficient visualisation of both the left and right eardrum
- Narrow ear canals
- Anatomy that precludes safe access to both the left and right eardrum
- Membrane >25% sclerosis
- Congenital or craniofacial abnormalities
- No available baseline audiometry and tympanometry
Sites / Locations
- Children's National Medical Center
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solo+ Tympanostomy Tube Device
Arm Description
The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
Outcomes
Primary Outcome Measures
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Rate of Adverse Events
The number and type of Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04148417
Brief Title
Clinical Study of the Solo+ Tympanostomy Tube Device
Official Title
Clinical Study of the Solo+ Tympanostomy Tube Device
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (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
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
Detailed Description
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
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
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solo+ Tympanostomy Tube Device
Arm Type
Experimental
Arm Description
The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
Intervention Type
Device
Intervention Name(s)
Solo+ Tympanostomy Tube Device
Intervention Description
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
Primary Outcome Measure Information:
Title
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
Description
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Time Frame
Intra-operative
Title
Rate of Adverse Events
Description
The number and type of Adverse Events
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Listed for bilateral tympanostomy tube insertion
Exclusion Criteria:
Anatomy that precludes sufficient visualisation of both the left and right eardrum
Narrow ear canals
Anatomy that precludes safe access to both the left and right eardrum
Membrane >25% sclerosis
Congenital or craniofacial abnormalities
No available baseline audiometry and tympanometry
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
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of the Solo+ Tympanostomy Tube Device
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