Clinical Study of Solo Tympanostomy Tube Device (TTD)

October 31, 2017 updated by: Nottingham University Hospitals NHS Trust

Post-Market Approval Study of the Solo Tympanostomy Tube Device

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solo TTD
Placement of tympanostomy tube with Solo TTD
Device: Solo TTD
Placement of tympanostomy tube with Solo TTD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Device Success
Time Frame: Intraoperative
Number of ears in which tube placement is achieved with the Solo TTD
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion from moderate sedation
Time Frame: Intraoperative
Number of patients requiring conversion from moderate sedation to general anaesthesia
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

University Hospitals of Derby and Burton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
AventaMed DAC

Investigators

  • Principal Investigator: Owen Judd, Royal Derby Hospitals NHS Foundation Trust
  • Principal Investigator: Tawakir Kamani, Sheffield Children's NHS Foundation Trust
  • Study Chair: Matija Daniel, Nottingham University Hospitals NHS Trust
  • Principal Investigator: Anand Kasbekar, Nottingham University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13IH026
  • 208475 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Plan to Share Individual Participant Data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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