Clinical Study of Solo Tympanostomy Tube Device (TTD)
Primary Purpose
Otitis Media, Middle Ear Effusion
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Solo TTD
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
Eligibility Criteria
Basic Inclusion Criteria:
- Listed for bilateral tympanostomy tube insertion only
Basic Exclusion Criteria:
- Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
- Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
- Patients in whom a reliable audiogram is not possible
Sites / Locations
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solo TTD
Arm Description
Placement of tympanostomy tube with Solo TTD
Outcomes
Primary Outcome Measures
Intraoperative Device Success
Number of ears in which tube placement is achieved with the Solo TTD
Secondary Outcome Measures
Conversion from moderate sedation
Number of patients requiring conversion from moderate sedation to general anaesthesia
Full Information
NCT ID
NCT02957578
First Posted
November 4, 2016
Last Updated
October 31, 2017
Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
AventaMed DAC, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02957578
Brief Title
Clinical Study of Solo Tympanostomy Tube Device (TTD)
Official Title
Post-Market Approval Study of the Solo Tympanostomy Tube Device
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
AventaMed DAC, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Children's NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Middle Ear Effusion
Keywords
Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solo TTD
Arm Type
Experimental
Arm Description
Placement of tympanostomy tube with Solo TTD
Intervention Type
Device
Intervention Name(s)
Solo TTD
Intervention Description
Placement of tympanostomy tube with Solo TTD
Primary Outcome Measure Information:
Title
Intraoperative Device Success
Description
Number of ears in which tube placement is achieved with the Solo TTD
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Conversion from moderate sedation
Description
Number of patients requiring conversion from moderate sedation to general anaesthesia
Time Frame
Intraoperative
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Basic Inclusion Criteria:
Listed for bilateral tympanostomy tube insertion only
Basic Exclusion Criteria:
Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
Patients in whom a reliable audiogram is not possible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Koufali
Email
researchsponsor@nuh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Olive O'Driscoll
Email
clinical@aventamed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Owen Judd
Organizational Affiliation
Royal Derby Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tawakir Kamani
Organizational Affiliation
Sheffield Children's NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matija Daniel
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anand Kasbekar
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anand Kasbekar
Email
clinical@aventamed.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plan to Share Individual Participant Data
Learn more about this trial
Clinical Study of Solo Tympanostomy Tube Device (TTD)
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