Otitis MediaNCT02957578
Clinical Study of Solo Tympanostomy Tube Device (TTD)
A study testing Solo TTD in people with Otitis Media and Middle Ear Effusion, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD) Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Otitis Media, Middle Ear Effusion
- What is being tested?
- Solo TTD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
Maria Koufali contact
Olive O'Driscoll contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Anand Kasbekar, clinical@aventamed.com
About this study
Official title: Post-Market Approval Study of the Solo Tympanostomy Tube Device
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
- Conditions
- Otitis Media, Middle Ear Effusion
- Being tested
- Solo TTD
- Keywords
- Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
- Medical subject headings
- Otitis Media, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solo TTDDevice
Placement of tympanostomy tube with Solo TTD
| Study group | Role | What they receive |
|---|---|---|
| Solo TTD | Experimental | Placement of tympanostomy tube with Solo TTD Receives: Device: Solo TTD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Device Success
Number of ears in which tube placement is achieved with the Solo TTD
Measured: Intraoperative
Secondary outcomes (1)
Conversion from moderate sedation
Number of patients requiring conversion from moderate sedation to general anaesthesia
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2018 (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 Otitis MediaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AventaMed DAC, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Owen Judd, Principal investigator, Royal Derby Hospitals NHS Foundation TrustTawakir Kamani, Principal investigator, Sheffield Children's NHS Foundation TrustMatija Daniel, Study chair, Nottingham University Hospitals NHS TrustAnand Kasbekar, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957578
- Sponsor's protocol ID
- 13IH026
- Other IDs
- 208475
- Status last verified
- Oct 2017
- First submitted
- 4 Nov 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No Plan to Share Individual Participant Data
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Approval Study of the Solo Tympanostomy Tube Device
- ClinicalTrials.gov ID
- NCT02957578
- Acronym / sponsor ID
- 13IH026
- Conditions
- Otitis Media, Middle Ear Effusion
- Keywords
- Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- AventaMed DAC, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Children's NHS Foundation Trust
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- 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.
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solo TTD | Experimental | Device: Solo TTDPlacement of tympanostomy tube with Solo TTD |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 TTDPlacement of tympanostomy tube with Solo TTD | Device | Solo TTD |
Primary outcome
Intraoperative Device Success
Time frame: Intraoperative
Number of ears in which tube placement is achieved with the Solo TTD
1 secondary outcome
Conversion from moderate sedation
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No. No Plan to Share Individual Participant Data
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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.
Maria Koufali contact
Olive O'Driscoll contact
Owen Judd principal investigator
Royal Derby Hospitals NHS Foundation Trust
Tawakir Kamani principal investigator
Sheffield Children's NHS Foundation Trust
Matija Daniel study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solo TTD in people with Otitis Media and Middle Ear Effusion, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 Maria Koufali (researchsponsor@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Device Success (time frame: Intraoperative). 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 1 Nov 2017.