Ear InfectionNCT03722160
Clinical Study of the Solo Tympanostomy Tube Device
A study testing Solo TympanostomyTube Device in people with Ear Infection and Otitis Media, run by AventaMed DAC at 3 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Ear Infection, Otitis Media
- What is being tested?
- Solo TympanostomyTube Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Sep 2018to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Listed for bilateral tympanostomy tube insertion
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby
- Completed
Queen's Medical Centre
Nottingham
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo-Garofolo
Trieste
Domenico Leonardo Grasso
About this study
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
Read the detailed description
The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
- Conditions
- Ear Infection, Otitis Media
- Being tested
- Solo TympanostomyTube Device
- Medical subject headings
- Otitis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Solo TympanostomyTube Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intra-operative
Rate of Adverse Events
The number and type of Adverse Events
Measured: Intra-operative, 2-6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start13 Sep 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AventaMed DAC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matija Daniel, Study chair, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722160
- Sponsor's protocol ID
- CSP001
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Solo Tympanostomy Tube Device
- ClinicalTrials.gov ID
- NCT03722160
- Acronym / sponsor ID
- CSP001
- Conditions
- Ear Infection, Otitis Media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AventaMed DACIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solo Tympanostomy Tube Device | Other | Device: Solo TympanostomyTube DeviceThe 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 |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Listed for bilateral tympanostomy tube insertion
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solo TympanostomyTube DeviceThe Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure. | Device | Solo Tympanostomy Tube Device |
Primary outcome
Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device
Time frame: Intra-operative
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Rate of Adverse Events
Time frame: Intra-operative, 2-6 weeks post-operative
The number and type of Adverse Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
Related trials for Ear Infection
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
RecruitingPhase 4
Nasal Antisepsis for C. Auris Prevention
Candida Auris Infection, Colonization, Asymptomatic
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matija Daniel study chair
Queen's Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solo TympanostomyTube Device in people with Ear Infection and Otitis Media, run by AventaMed DAC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olive O'Driscoll (+353 21 492 8980, clinical@aventamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device (time frame: Intra-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.