Otitis MediainVENT-IONCT01324271
inVENT-In-Office Study
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
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting. Read more about this study
- Who is it for?
- Ages 6 months and older
- 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
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old
- Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
Who cannot join
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- 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 (Tula™) Delivery System In-Office
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
- Conditions
- Otitis Media
- Being tested
- Acclarent Tympanostomy Tube Delivery system (TTDS)
- Keywords
- Tympanostomy tube placement
- 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
Also called Tula™
placement of tympanostomy tube under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Tympanostomy tube placement | Experimental | placement of tympanostomy tube under local anesthesia in office/clinic setting 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.
Percentage of Subjects With In-office Tube Placement Procedure Success
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Measured: Day 0
Percentage of Tubes Successfully Placed Using a TTDS Device
Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.
A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
Measured: Day 0
Secondary outcomes (1)
Number of Retained (TTDS-placed) Tubes
Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
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
- 85 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
- NCT01324271
- Sponsor's protocol ID
- CPR005016
- Acronym
- inVENT-IO
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2011
- Last updated
- 6 Aug 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office
- ClinicalTrials.gov ID
- NCT01324271
- Acronym / sponsor ID
- inVENT-IO / CPR005016
- Conditions
- Otitis Media
- Keywords
- Tympanostomy tube placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 25 Nov 2014
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 the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
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 placement | Experimental | Device: Acclarent Tympanostomy Tube Delivery system (TTDS)placement of tympanostomy tube under local anesthesia in office/clinic setting |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old
- Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
Key exclusion criteria (5 listed)
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- 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
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)Also: Tula™placement of tympanostomy tube under local anesthesia | Device | Tympanostomy tube placement |
Primary outcome
Percentage of Subjects With In-office Tube Placement Procedure Success
Time frame: Day 0
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Percentage of Tubes Successfully Placed Using a TTDS Device
Time frame: Day 0
Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only. A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
1 secondary outcome
Number of Retained (TTDS-placed) Tubes
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 3 inclusion and 5 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 6 Aug 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 Nov 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?
Percentage of Subjects With In-office Tube Placement Procedure Success (time frame: Day 0). 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 6 Aug 2024.