Clinical Study of Solo Tympanostomy Tube Device (TTD)

NCT ID: NCT02957578

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-11-30

Brief Summary

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

Detailed Description

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Conditions

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Otitis Media Middle Ear Effusion

Keywords

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Tympanostomy Tube Ventilation Tube Grommet Otitis Media Middle Ear Effusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Solo TTD

Placement of tympanostomy tube with Solo TTD

Group Type EXPERIMENTAL

Solo TTD

Intervention Type DEVICE

Placement of tympanostomy tube with Solo TTD

Interventions

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Solo TTD

Placement of tympanostomy tube with Solo TTD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Listed for bilateral tympanostomy tube insertion only

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AventaMed DAC

INDUSTRY

Sponsor Role collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Owen Judd

Role: PRINCIPAL_INVESTIGATOR

Royal Derby Hospitals NHS Foundation Trust

Tawakir Kamani

Role: PRINCIPAL_INVESTIGATOR

Sheffield Children's NHS Foundation Trust

Matija Daniel

Role: STUDY_CHAIR

Nottingham University Hospitals NHS Trust

Anand Kasbekar

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Locations

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Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Maria Koufali

Role: CONTACT

Email: [email protected]

Olive O'Driscoll

Role: CONTACT

Email: [email protected]

Facility Contacts

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Anand Kasbekar

Role: primary

Other Identifiers

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208475

Identifier Type: OTHER

Identifier Source: secondary_id

13IH026

Identifier Type: -

Identifier Source: org_study_id