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Clinical Study of Solo Tympanostomy Tube Device (TTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957578
Recruitment Status : Unknown
Verified October 2017 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : November 6, 2016
Last Update Posted : November 1, 2017
Sponsor:
Collaborators:
AventaMed DAC
University Hospitals of Derby and Burton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Study Description
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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)

Condition or disease Intervention/treatment Phase
Otitis Media Middle Ear Effusion Device: Solo TTD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Approval Study of the Solo Tympanostomy Tube Device
Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arms and Interventions
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Arm Intervention/treatment
Experimental: Solo TTD
Placement of tympanostomy tube with Solo TTD
 Device: Solo TTD
Placement of tympanostomy tube with Solo TTD


Outcome Measures
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Primary Outcome Measures :
  1. Intraoperative Device Success [ Time Frame: Intraoperative ]
    Number of ears in which tube placement is achieved with the Solo TTD


Secondary Outcome Measures :
  1. Conversion from moderate sedation [ Time Frame: Intraoperative ]
    Number of patients requiring conversion from moderate sedation to general anaesthesia


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957578


Contacts
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Contact: Maria Koufali researchsponsor@nuh.nhs.uk
Contact: Olive O'Driscoll clinical@aventamed.com

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Anand Kasbekar       clinical@aventamed.com   
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
AventaMed DAC
University Hospitals of Derby and Burton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
Investigators
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Principal Investigator: Owen Judd Royal Derby Hospitals NHS Foundation Trust
Principal Investigator: Tawakir Kamani Sheffield Children's Hospital NHS Foundation Trust
Study Chair: Matija Daniel Nottingham University Hospitals NHS Trust
Principal Investigator: Anand Kasbekar Nottingham University Hospitals NHS Trust
More Information
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02957578    
Other Study ID Numbers: 13IH026
208475 ( Other Identifier: IRAS )
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan to Share Individual Participant Data
Keywords provided by Nottingham University Hospitals NHS Trust:
Tympanostomy Tube
Ventilation Tube
Grommet
Otitis Media
Middle Ear Effusion
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases