NCT02957578

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

November 4, 2016

Last Update Submit

October 31, 2017

Conditions

Otitis MediaMiddle Ear Effusion

Keywords

Tympanostomy TubeVentilation TubeGrommetOtitis MediaMiddle Ear Effusion

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Device Success

    Number of ears in which tube placement is achieved with the Solo TTD

    Intraoperative

Secondary Outcomes (1)

  • Conversion from moderate sedation

    Intraoperative

Study Arms (1)

Solo TTD

EXPERIMENTAL

Placement of tympanostomy tube with Solo TTD

Device: Solo TTD

Interventions

Solo TTDDEVICE

Placement of tympanostomy tube with Solo TTD

Solo TTD

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Listed for bilateral tympanostomy tube insertion only

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Otitis MediaOtitis Media with Effusion

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Owen Judd

    Royal Derby Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Tawakir Kamani

    Sheffield Children's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Matija Daniel

    Nottingham University Hospitals NHS Trust

    STUDY CHAIR

  • Anand Kasbekar

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Koufali

CONTACT

researchsponsor@nuh.nhs.uk

Olive O'Driscoll

CONTACT

clinical@aventamed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 7, 2016

Study Start

December 1, 2016

Primary Completion

September 1, 2018

Study Completion

November 1, 2019

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

No Plan to Share Individual Participant Data

Locations

GB(1)