Otitis MediainVENT2NCT02150044
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
A study testing Acclarent Tympanostomy Tube Delivery System (TTDS). in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otitis Media
- What is being tested?
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
Who cannot join
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology requiring T-tubes
- Stenosed ear canal
- Anatomy that precludes sufficient visualization of and access to the tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
- Conditions
- Otitis Media
- Being tested
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acclarent Tympanostomy Tube Delivery System (TTDS).Device
tympanostomy tube delivery system
| Study group | Role | What they receive |
|---|---|---|
| Tympanostomy tube | Experimental | Performance and safety of tympanostomy tube delivery system Receives: Device: Acclarent Tympanostomy Tube Delivery System (TTDS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ear Outcome Success
Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Measured: Day 0 (at procedure visit)
Secondary outcomes (2)
Procedure Success
Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Measured: Day 0 (at procedure visit)
Tube Retention
Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2010
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150044
- Sponsor's protocol ID
- CPR005008
- Acronym
- inVENT2
- Status last verified
- Jul 2024
- First submitted
- 27 May 2014
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
- ClinicalTrials.gov ID
- NCT02150044
- Acronym / sponsor ID
- inVENT2 / CPR005008
- Conditions
- Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tympanostomy tube | Experimental | Device: Acclarent Tympanostomy Tube Delivery System (TTDS).Performance and safety of tympanostomy tube delivery system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
Key exclusion criteria (8 listed)
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology requiring T-tubes
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 |
|---|---|---|
| Acclarent Tympanostomy Tube Delivery System (TTDS).tympanostomy tube delivery system | Device | Tympanostomy tube |
Primary outcome
Ear Outcome Success
Time frame: Day 0 (at procedure visit)
Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
2 secondary outcomes
Procedure Success
Time frame: Day 0 (at procedure visit)
Tube Retention
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Otitis Media
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)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acclarent Tympanostomy Tube Delivery System (TTDS). in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 12 Jul 2024. 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 States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ear Outcome Success (time frame: Day 0 (at procedure visit)). 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 12 Jul 2024.