NCT02957578|Unknown
Clinical Study of Solo Tympanostomy Tube Device (TTD)
Post-Market Approval Study of the Solo Tympanostomy Tube Device
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Post-Market Approval Study of the Solo Tympanostomy Tube Device
Sponsor study identifier
Secondary identifiers
OTHER · IRAS
interventional
20
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 4, 2016
Actual (reported)November 7, 2016
Actual (reported)December 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intraoperative Device Success
Number of ears in which tube placement is achieved with the Solo TTD
Intraoperative
Conversion from moderate sedation
Intraoperative
Placement of tympanostomy tube with Solo TTD
Placement of tympanostomy tube with Solo TTD
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Owen Judd
Royal Derby Hospitals NHS Foundation Trust
Tawakir Kamani
Sheffield Children's NHS Foundation Trust
Matija Daniel
Nottingham University Hospitals NHS Trust
Anand Kasbekar
Nottingham University Hospitals NHS Trust
First Submitted
November 4, 2016
First Posted
November 7, 2016
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2018
Estimated (date passed)Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 1, 2017
Record last verified: 2017-10
No Plan to Share Individual Participant Data
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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