A Phase 3 interventional study of Iontophoresis & tube placement and Tube placement in OME - Otitis Media With Effusion and AOM - Acute Otitis Media, sponsored by Tusker Medical. Completed at 19 sites in 2 countries. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Tusker Medical (part of Smith & Nephew, Inc.) · Phase 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 2nd largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2017, is one of 6 in phase 3, and was the 17th 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 to 12 Years · 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. 2 started in 2017.
This study's enrollment of 370 is above 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:
Tusker Medical is the lead sponsor of 3 studies on the registry; none are open to participants now.
Tusker Medical 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.
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
The objective of this study is to evaluate effectiveness and safety of tympanostomy tube (TT) placement in children following local anesthesia in a physician's clinic setting (henceforth referred to as 'in-office'). Local anesthesia using Tymbion, a lidocaine-based anesthetic, is delivered by the Tula Iontophoresis System (IPS) and TT placement is implemented by the Tula Tube Delivery System (TDS).
The IPS will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The Iontophoresis System consists of an Iontophoresis Control Unit, Iontophoresis Earsets and a return electrode patch. The Control Unit monitors and delivers a fixed amount of charge (ie, dose) to the patient through the Earsets(s) and alerts the operator when charge delivery is complete. The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
The TDS is a mechanical device that integrates a myringotomy blade, tympanostomy tube and tube inserter for TT placement with a user-controlled activation. The study will use the TDS with a grommet-type tube.
This pivotal study will include up to 422 children ages 6 months through 12 years indicated for tympanostomy tube placement enrolled at approximately 15 to 25 investigational centers in the US and Canada. The pivotal cohort consists of 222 subjects. In addition, up to 100 subjects will be enrolled as lead-in procedures in the OR using the TDS and up to 100 subjects will be enrolled as lead-in procedure in-office (using IPS and TDS) as the surgeons' initial experience with the technology prior to enrolling into the pivotal cohort.
All pivotal and lead-in subjects will follow the same study protocol assessments and visit schedule consisting of a screening visit, procedure visit and 3-week, 6 month, 12 month, 18 month, and 24 month post-procedure follow-up visits. Lead-in procedures will be analyzed separately from the pivotal pediatric cohort.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.
Combination Product: Iontophoresis & tube placement
Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator).
Combination Product: Iontophoresis & tube placement
Tubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator).
Device: Tube placement
Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.
Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Procedural Success:
Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Time frame: Day of Procedure (Day 0) Immediately following tube placement
Tube Placement Tolerability
Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Time frame: Day of Procedure (Day 0) Immediately following tube placement
Tube Patency
Count (and percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube was successfully placed, with functionally patent tube(s) at the 3-week post-procedure follow-up visit. Note- thus secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Patency endpoint for the ear that was successful.
Time frame: 3 Weeks Post Procedure
Tube Retention
Count (percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube(s) was successfully placed, with presence of a Tusker Medical tube across the TM in all successfully treated ears at the 3-week post-procedure follow-up visit. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Retention endpoint for the ear that was successful.
Time frame: 3 Weeks Post Procedure
Anesthesia Effectiveness
Count (percentage) of subjects in the pivotal cohort, who completed iontophoresis for all indicated ears, with adequate anesthesia for TT placement in all treated ears as determined by physician's evaluation of TM anesthesia prior to tube placement. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Time frame: Day of Procedure (Day 0)
| Milestone | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort |
|---|---|---|---|
| Started | 241 | 59 | 70 |
| Treated | 222 | 47 | 68 |
| Completed | 222 | 47 | 68 |
| Not completed | 19 | 12 | 2 |
| Withdrew: Screen failure | 14 | 9 | 1 |
| Withdrew: Withdrawal before treatment | 3 | 1 | 1 |
| Withdrew: Iontophoresis fill/no iontophoresis | 2 | 2 | 0 |
Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
| Participants | Pivotal Cohort (6 Month to <5 Year Old Children) | Pivotal Cohort (5 Through 12 Year Old Children) |
|---|---|---|
| Procedural Success: | 103 | 91 |
Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
| score on a scale | Pivotal Cohort (5 Through 12 Year Olds) |
|---|---|
| Tube Placement Tolerability | 3.30 ± 3.39 |
Count (and percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube was successfully placed, with functionally patent tube(s) at the 3-week post-procedure follow-up visit. Note- thus secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Patency endpoint for the ear that was successful.
| Participants | Pivotal Cohort |
|---|---|
| Tube Patency | 191 |
Count (percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube(s) was successfully placed, with presence of a Tusker Medical tube across the TM in all successfully treated ears at the 3-week post-procedure follow-up visit. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Retention endpoint for the ear that was successful.
| Participants | Pivotal Cohort |
|---|---|
| Tube Retention | 206 |
Count (percentage) of subjects in the pivotal cohort, who completed iontophoresis for all indicated ears, with adequate anesthesia for TT placement in all treated ears as determined by physician's evaluation of TM anesthesia prior to tube placement. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
| Participants | Pivotal Cohort |
|---|---|
| Anesthesia Effectiveness | 206 |
Collected over Procedure through most recent follow-up visit with mean follow-up of 14.3 months (all cohorts combined). Individual cohort mean follow-up time is 11.3 months for OR Lead-In Cohort, 14.1 months for Office Lead-In Cohort, and 15.3 months for Pivotal Cohort.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OR Lead-In Cohort (Subjects Treated in OR) | 0/68 (0%) | 4/68 (5.9%) | 28/68 (41.2%) |
| Office Lead-In Cohort (Subjects Treated in Office) | 0/47 (0%) | 0/47 (0%) | 22/47 (46.8%) |
| Pivotal Cohort (Subjects Treated in Office) | 0/222 (0%) | 3/222 (1.4%) | 79/222 (35.6%) |
| Event | OR Lead-In Cohort (Subjects Treated in OR) | Office Lead-In Cohort (Subjects Treated in Office) | Pivotal Cohort (Subjects Treated in Office) |
|---|---|---|---|
| Respiratory Syncytial Virus InfectionRespiratory, thoracic and mediastinal disorders | 2/68 | 0/47 | 1/222 |
| Wrist FractureMusculoskeletal and connective tissue disorders | 1/68 | 0/47 | 0/222 |
| Velopharyngeal InsufficiencyRespiratory, thoracic and mediastinal disorders | 1/68 | 0/47 | 0/222 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/68 | 0/47 | 2/222 |
| ConstipationGastrointestinal disorders | 0/68 | 0/47 | 1/222 |
| InfluenzaRespiratory, thoracic and mediastinal disorders | 0/68 | 0/47 | 1/222 |
| Event | OR Lead-In Cohort (Subjects Treated in OR) | Office Lead-In Cohort (Subjects Treated in Office) | Pivotal Cohort (Subjects Treated in Office) |
|---|---|---|---|
| OtorrheaEar and labyrinth disorders | 19/68 | 7/47 | 60/222 |
| Otitis MediaEar and labyrinth disorders | 13/68 | 11/47 | 61/222 |
| Occluded TubeEar and labyrinth disorders | 13/68 | 5/47 | 51/222 |
| Ear PainEar and labyrinth disorders | 6/68 | 9/47 | 29/222 |
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 9/68 | 3/47 | 18/222 |
| Ear infectionEar and labyrinth disorders | 6/68 | 4/47 | 12/222 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 6/68 | 4/47 | 10/222 |
| Inadequate AnesthesiaEar and labyrinth disorders | 0/68 | 4/47 | 8/222 |
| Pharyngitis StreptococcalRespiratory, thoracic and mediastinal disorders | 3/68 | 4/47 | 17/222 |
| Middle ear effusionEar and labyrinth disorders | 2/68 | 4/47 | 15/222 |
| Age, Continuous(years) | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort | Total |
|---|---|---|---|---|
| Mean | 4.7 ± 3.18 | 4.8 ± 3.10 | 3.4 ± 2.55 | 4.5 ± 3.09 |
| Sex: Female, Male(Participants) | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort | Total |
|---|---|---|---|---|
| Female | 93 | 20 | 28 | 141 |
| Male | 129 | 27 | 40 | 196 |
| Ethnicity (NIH/OMB)(Participants) | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort | Total |
|---|---|---|---|---|
| Hispanic or Latino | 31 | 6 | 14 | 51 |
| Not Hispanic or Latino | 191 | 40 | 54 | 285 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 4 | 0 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 24 | 6 | 6 | 36 |
| White | 183 | 35 | 53 | 271 |
| More than one race | 4 | 1 | 0 | 5 |
| Unknown or Not Reported | 7 | 5 | 6 | 18 |
| Region of Enrollment(participants) | Pivotal Cohort | Office Lead-In Cohort | OR Lead-In Cohort | Total |
|---|---|---|---|---|
| Canada | 3 | 4 | 4 | 11 |
| United States | 219 | 43 | 64 | 326 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Feb 2019, 15 months.
Results were first posted in Jan 2020, 11 months after primary completion.
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