Otitis Media With EffusionPhase 2/3inVENT-ORNCT01202578

Evaluation of the Tympanostomy Tube Delivery System

A Phase 2/3 study testing tympanostomy tube in people with Otitis Media With Effusion and Acute Otitis Media, run by Integra LifeSciences Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media. Read more about this study

Who is it for?: Ages 6 months and older
Conditions the study is for: Otitis Media With Effusion, Acute Otitis Media
What is being tested?: tympanostomy tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 4 sitesUnited States
Study dates: Sep 2010to Dec 2010
Phase: Phase 2/3
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

Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

Who cannot join

Reaction to anesthesia
Markedly atrophic, 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 visualization and access to tympanic membrane
Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Evergreen Sinus Center
Kirkland, Washington, 98034
Advanced ENT and Allergy
Louisville, Kentucky, 40207
South Coast ENT
Port Saint Lucie, Florida, 34952
Ear Medical Group
San Antonio, Texas, 78240

Other trials in United States

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

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Conditions: Otitis Media With Effusion, Acute Otitis Media
Being tested: tympanostomy tube
Medical subject headings: Otitis Media with Effusion, Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tympanostomy tubeDevice
tympanostomy tube delivery system

Study groups in NCT01202578
Study group	Role	What they receive
tympanostomy tube	Experimental	performance and safety of tympanostomy tube delivery system Receives: Device: tympanostomy tube

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of Tympanostomy Tube (TT) Delivery System
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Measured: 7 days
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Measured: 0 days

Secondary outcomes (2)

Proportion of Subjects With Procedure Success
Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
Measured: 0 days
Tube Retention
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Dec 2010

First posted16 Sep 2010 (estimated)
Study startSep 2010
Primary completionNov 2010
Study completionDec 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 Media With EffusionStudies 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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01202578
Sponsor's protocol ID: CPR005013
Acronym: inVENT-OR
Status last verified: Jul 2024
First submitted: 13 Sep 2010
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
SWIR Otoscopy Study
Otitis Media, Otitis Media Chronic

All Otitis Media With Effusion trials

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 Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
ClinicalTrials.gov ID: NCT01202578
Acronym / sponsor ID: inVENT-OR / CPR005013
Conditions: Otitis Media With Effusion, Acute Otitis Media
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Acclarent
Study start: Sep 2010
Primary completion: Nov 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 16 Sep 2010 (estimated)
Results: Posted 11 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

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: tympanostomy tubeperformance and safety of tympanostomy tube delivery system

Who may qualify

Ages: 6 months and older
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 or acute otitis media and scheduled to undergo tympanostomy tube insertion

Key exclusion criteria (8 listed)

Reaction to anesthesia
Markedly atrophic, 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
tympanostomy tubetympanostomy tube delivery system	Device	tympanostomy tube

Primary outcome

Safety of Tympanostomy Tube (TT) Delivery System
Time frame: 7 days
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Device Success
Time frame: 0 days
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.

2 secondary outcomes

Proportion of Subjects With Procedure Success
Time frame: 0 days
Tube Retention
Time frame: 7 days

Results and safety

Results posted to the registry on 11 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tympanostomy Tube Placement Using the Tube Delivery System	53	53

Primary outcome: Safety of Tympanostomy Tube (TT) Delivery System

Time frame: 7 days. Number (95% Confidence Interval). Unit: percentage of ears

Measure	Tympanostomy Tube Placement Using the Tube Delivery System n = 53
Value	0.0 (0.0 to 3.6)

Population analysed: Subjects in whom TTDS was attempted.

Primary outcome: Device Success

Time frame: 0 days. Number (95% Confidence Interval). Unit: percentage of devices

Measure	Tympanostomy Tube Placement Using the Tube Delivery System n = 53
Value	94.1 (87.5 to 97.8)

Population analysed: Device Success is evaluated on a per device basis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Events	0 of 53 (0%)	4 of 53 (7.5%)	Not reported

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.

Related trials for Otitis Media With Effusion

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
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
SWIR Otoscopy Study
Otitis Media, Otitis Media Chronic

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.

Kenneth Faw, MD principal investigator

Evergreen Sinus Center

Andrew Gould, MD principal investigator

Advanced ENT and Allergy

Charles Syms, MD principal investigator

Ear Medical Group

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tympanostomy tube in people with Otitis Media With Effusion and Acute Otitis Media, run by Integra LifeSciences Corporation at 4 sites 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 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 4 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 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?

Safety of Tympanostomy Tube (TT) Delivery System (time frame: 7 days). 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?

On the ClinicalTrials.gov record for NCT01202578.

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.