NCT04148417

Brief Summary

The objective of this study is to evaluate 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

43
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 Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

October 30, 2019

Last Update Submit

January 23, 2024

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

    24 months

Study Arms (1)

Solo+ Tympanostomy Tube Device

EXPERIMENTAL

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+ Tympanostomy Tube Device

Interventions

Solo+ Tympanostomy Tube 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 (2)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

OtitisOtitis Media

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Matija Daniel

    Queen's Medical Center

    STUDY CHAIR

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 30, 2019

First Posted

November 1, 2019

Study Start

February 9, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)