Back to resultsClinical Study of the Solo Tympanostomy Tube Device
Primary Purpose
Ear Infection, Otitis Media
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Solo TympanostomyTube 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
- IRCCS Burlo-GarofoloRecruiting
- Royal Derby HospitalRecruiting
- Queen's Medical Centre
Arms of the Study
Arm 1
Arm Type
Other
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
NCT03722160
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
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (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
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is post-approval evaluation of 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
Other
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 TympanostomyTube 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
Intra-operative, 2-6 weeks post-operative
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olive O'Driscoll
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
IRCCS Burlo-Garofolo
City
Trieste
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Leonardo Grasso
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen's Medical Centre
City
Nottingham
Country
United Kingdom
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers
Learn more about this trial
Clinical Study of the Solo Tympanostomy Tube Device
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