A Phase 2/3 interventional study of tympanostomy tube in Otitis Media With Effusion and Acute Otitis Media, sponsored by Integra LifeSciences Corporation. Completed at 4 sites in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Integra LifeSciences Corporation · Phase 2/3, Interventional, and Treatment
Among 27 studies in Otitis Media with Effusion with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Otitis Media with Effusion · United States.
Among the 27 studies in Otitis Media with Effusion with a site in United States, this one is the 12th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2010, is the only one in phase 2/3, and was the 9th registered.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
Browse Otitis Media with Effusion studies →7 of the 27 studies in Otitis Media with Effusion with a site in United States are open now. Recruiting first, the newest first:
ClinQure, Inc. · Sites in United States
Stanford University · Sites in United States
Smith & Nephew, Inc. · Sites in United States
Medical College of Wisconsin · Sites in United States
Philip Perez · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Otitis Media with Effusion studies recruiting now, 1 (13%) set no upper age limit and 7 (88%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 6 Months and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 7 · Phase 4 1
First in 1997; this study’s year is marked. 1 started in 2010.
This study's enrollment of 53 is below the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Median enrollment 82 across the 20 interventional studies, 194 across the 6 observational. Of the 17 that completed or were terminated, 12 (71%) have results posted.
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13 of 27 have an industry lead sponsor. The 10 most frequent:
Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Integra LifeSciences Corporation has 2 studies filed under Otitis Media with Effusion — fewer than ten, so there is no comparison to draw.
4 of the studies in Otitis Media with Effusion with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05353569Medical College of WisconsinCoherent Optical Detection of Middle Ear Disease | 2027-04 |
| NCT06944795Stanford UniversitySWIR Otoscopy Study | 2027-04-30 |
| NCT07625657ClinQure, Inc.CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes | 2027-06 |
| NCT07777302Philip PerezEarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults | 2027-11-30 |
Among the 27 studies in Otitis Media with Effusion with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
performance and safety of tympanostomy tube delivery system
Device: tympanostomy tube
tympanostomy tube delivery system
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.
Time frame: 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.
Time frame: 0 days
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.
Time frame: 0 days
Tube Retention
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Time frame: 7 days
Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.
| Milestone | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Started | 53 |
| Completed | 53 |
| Not completed | 0 |
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.
| percentage of ears | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Safety of Tympanostomy Tube (TT) Delivery System | 0.0 (0.0 to 3.6) |
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.
| percentage of devices | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Device Success | 94.1 (87.5 to 97.8) |
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.
| percentage of participants | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Proportion of Subjects With Procedure Success | 100 (93.3 to 100.0) |
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
| percentage of tubes retained | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Tube Retention | 99.0 (94.3 to 100.0) |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Events | — | 0/53 (0%) | 4/53 (7.5%) |
| Event | Safety Events |
|---|---|
| Tube Lumen OcclusionEar and labyrinth disorders | 4/53 |
| Age, Continuous(years) | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Mean | 2.68 ± 2.49 |
| Age, Customized(participants) | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| <=5 years | 47 |
| >5 years | 6 |
| Sex: Female, Male(Participants) | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Female | 22 |
| Male | 31 |
| Region of Enrollment(participants) | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| United States | 53 |
The record gives a start of Sep 2010, a primary completion of Nov 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 3 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Integra LifeSciences Corporation →