Clinical Study of Solo Tympanostomy Tube Device (TTD) | NCT02957578

Studies
Clinical Study of Solo Tympanostomy Tube Device (TTD)

NCT02957578

Sponsor

Nottingham University Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Nov 1, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Otitis Media
Middle Ear Effusion

Interventions

Solo TTD

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
208475	Other Identifier	IRAS

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Sep 2018Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Nov 4, 2016

First Submission Date that Met QC Criteria

Nov 4, 2016

First Posted Date

Nov 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2017

Last Update Posted Date

Nov 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Nottingham University Hospitals NHS TrustOTHER

Collaborators

Name	Class
AventaMed DAC	INDUSTRY
University Hospitals of Derby and Burton NHS Foundation Trust	OTHER
Sheffield Children's NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Solo TTD	Experimental	Placement of tympanostomy tube with Solo TTD	Device: Solo TTD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solo TTD	Device	Placement of tympanostomy tube with Solo TTD	Solo TTD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Koufali	Contact			researchsponsor@nuh.nhs.uk
Olive O'Driscoll	Contact			clinical@aventamed.com

Overall Officials

Name	Affiliation	Role
Owen Judd	Royal Derby Hospitals NHS Foundation Trust	Principal Investigator
Tawakir Kamani	Sheffield Children's NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham University Hospitals NHS Trust	Recruiting	Nottingham		NG7 2UH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No Plan to Share Individual Participant Data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media
D010034	Otitis Media with Effusion

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided