NCT03722160

Brief Summary

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
2 countries

3 active sites

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

Study Start

First participant enrolled

September 13, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

October 25, 2018

Last Update Submit

October 25, 2019

Conditions

Ear InfectionOtitis Media

Outcome Measures

Primary Outcomes (2)

  • Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device

    The number of ears in which the Solo Tympanostomy Tube Device tube is placed

    Intra-operative

  • Rate of Adverse Events

    The number and type of Adverse Events

    Intra-operative, 2-6 weeks post-operative

Study Arms (1)

Solo Tympanostomy Tube Device

OTHER

The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure

Device: Solo TympanostomyTube Device

Interventions

Solo TympanostomyTube DeviceDEVICE

The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Solo Tympanostomy Tube Device

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Listed for bilateral tympanostomy tube insertion

You may not qualify if:

  • Anatomy that precludes sufficient visualisation of both the left and right eardrum
  • Narrow ear canals
  • Anatomy that precludes safe access to both the left and right eardrum
  • Membrane \>25% sclerosis
  • Congenital or craniofacial abnormalities
  • No available baseline audiometry and tympanometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS Burlo-Garofolo

Trieste, Italy

RECRUITING

Royal Derby Hospital

Derby, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, United Kingdom

COMPLETED

MeSH Terms

Conditions

OtitisOtitis Media

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Matija Daniel

    Queen's Medical Center

    STUDY CHAIR

Central Study Contacts

Olive O'Driscoll

CONTACT

+353 21 492 8980clinical@aventamed.com

Study Design

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

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 26, 2018

Study Start

September 13, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers

Locations

IT(1)GB(2)