Otitis MediainVENT-visIOnNCT01444391
inVENT-visIOn Study
A study testing Tympanostomy tube placement (Acclarent iontophoresis device) 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 (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis 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?
- Tympanostomy tube placement (Acclarent iontophoresis device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 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)
- No history of sensitivity or reaction to anesthesia chosen for the procedure
Who cannot join
- Pregnant or lactating females
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- 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.
United States1 site
South Coast Ear, Nose, & Throat
Port Saint Lucie, Florida, 34952
About this study
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.
- Conditions
- Otitis Media
- Being tested
- Tympanostomy tube placement (Acclarent iontophoresis device)
- Keywords
- Tympanostomy tube placement, iontophoresis
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanostomy tube placement (Acclarent iontophoresis device)Device
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
| Study group | Role | What they receive |
|---|---|---|
| Tympanostomy Tube Placement | Experimental | Not described Receives: Device: Tympanostomy tube placement (Acclarent iontophoresis device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Adverse events which are procedural, serious, and device-related.
Measured: Procedure through 2 weeks post-procedure
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
Measured: Day 0 (day of procedure)
Secondary outcomes (3)
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.
Measured: Day 0 (day of procedure)
Procedure Tolerability
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
Measured: Day 0 (day of procedure)
Tube Retention
Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
Measured: 2 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionJun 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Jacob W. Zeiders, M.D., Principal investigator, South Coast Ear, Nose & Throat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444391
- Sponsor's protocol ID
- CPR005022
- Acronym
- inVENT-visIOn
- Status last verified
- Jul 2024
- First submitted
- 23 Sep 2011
- 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 and Iontophoresis Systems In-Office
- ClinicalTrials.gov ID
- NCT01444391
- Acronym / sponsor ID
- inVENT-visIOn / CPR005022
- Conditions
- Otitis Media
- Keywords
- Tympanostomy tube placement, iontophoresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Posted 19 Sep 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 (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis 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: Tympanostomy tube placement (Acclarent iontophoresis device) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 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)
- No history of sensitivity or reaction to anesthesia chosen for the procedure
Key exclusion criteria (8 listed)
- Pregnant or lactating females
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize 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 |
|---|---|---|
| Tympanostomy tube placement (Acclarent iontophoresis device)Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device | Device | Tympanostomy Tube Placement |
Primary outcome
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Time frame: Procedure through 2 weeks post-procedure
Adverse events which are procedural, serious, and device-related.
Device Success
Time frame: Day 0 (day of procedure)
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
3 secondary outcomes
Procedure Success
Time frame: Day 0 (day of procedure)
Procedure Tolerability
Time frame: Day 0 (day of procedure)
Tube Retention
Time frame: 2 weeks post-procedure
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
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Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
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Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute 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.
Jacob W. Zeiders, M.D. principal investigator
South Coast Ear, Nose & Throat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanostomy tube placement (Acclarent iontophoresis device) 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 4 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 19 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?
Number of Subjects With Procedural, Serious and Device-related Adverse Events. (time frame: Procedure through 2 weeks post-procedure). 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 12 Jul 2024.