An interventional study of Acclarent Tympanostomy Tube Delivery System in Otitis Media With Effusion, sponsored by Integra LifeSciences Corporation. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Integra LifeSciences Corporation · Not applicable, 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 16th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2009, is one of 10 with no phase, and was the 8th 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: 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 2009.
This study's enrollment of 16 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.
This tab as a report to print or save as PDF → With an account.
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.
This tab as a report to print or save as PDF → With an account.
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
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:
Tympanostomy tube placement with Acclarent tube delivery system
Device: Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
Device Success
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
Time frame: At procedure visit
Cross-Over to Manual Myringotomy and Tube Placement
Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.
Time frame: at procedure visit
Tube Retention
Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).
Time frame: two weeks post-procedure
Eligible patients presenting to the clinical practice and for whom tympanostomy tube (TT) insertion was recommended were offered the opportunity to participate in the study. Recruitment period was May-June 2009.
| Milestone | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
| devices | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Device Success | 21 (xx.x to xx.x) |
Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.
| number of ears | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Cross-Over to Manual Myringotomy and Tube Placement | 3 (xx.x to xx.x) |
Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).
| retained tubes | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Tube Retention | 24 (xx.x to xx.x) |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tympanostomy Tube Delivery System (TTDS) | — | 0/16 (0%) | 2/16 (12.5%) |
| Event | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| tympanic membrane perforationEar and labyrinth disorders | 2/16 |
| Age, Customized(participants) | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| <=5 years | 14 |
| >5 years | 2 |
| Sex: Female, Male(Participants) | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Female | 9 |
| Male | 7 |
| Region of Enrollment(participants) | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| United States | 16 |
The record gives a start of Mar 2009, a primary completion of Jun 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 5 years 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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Integra LifeSciences Corporation →