Trial · NCT03323736
In-Office Tympanostomy Tube Placement in Children (OTTER)
NCT03323736, Phase 3, Completed, Tusker Medical; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. In-Office Tympanostomy Tube Placement in Children (OTTER). Trials, record NCT03323736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03323736
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- In-Office Tympanostomy Tube Placement in Children (OTTER)
- NCT number
- NCT03323736
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Tusker Medical
- Conditions
- OME - Otitis Media With Effusion, AOM - Acute Otitis Media
- Interventions
- Iontophoresis & tube placement, Tube placement
- First posted
- 2017-10-27
- Last updated
- 2022-05-26
- Results first posted
- 2020-01-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Procedural Success: | Day of Procedure (Day 0) Immediately following tube placement | 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. |
| Primary | Tube Placement Tolerability | Day of Procedure (Day 0) Immediately following tube placement | 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. |
| Secondary | Tube Patency | 3 Weeks Post Procedure | 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. |
| Secondary | Tube Retention | 3 Weeks Post Procedure | 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. |
| Secondary | Anesthesia Effectiveness | Day of Procedure (Day 0) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Procedural Success: | Day of Procedure (Day 0) Immediately following tube placement | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Tube Placement Tolerability | Day of Procedure (Day 0) Immediately following tube placement | Subjects with successful tube placement only. Note - 2 subjects were excluded from analysis because they did not self-report their pain scores, resulting in 89 participants analyzed. | score on a scale | MEAN |
| SECONDARY | Tube Patency | 3 Weeks Post Procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tube Retention | 3 Weeks Post Procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Anesthesia Effectiveness | Day of Procedure (Day 0) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Procedural Success: | Pivotal Cohort (6 Month to <5 Year Old Children) | 103 | Participants | ||
| Procedural Success: | Pivotal Cohort (5 Through 12 Year Old Children) | 91 | Participants | ||
| Tube Placement Tolerability | Pivotal Cohort (5 Through 12 Year Olds) | 3.30 | Standard Deviation 3.39 | score on a scale | |
| Tube Patency | Pivotal Cohort | 191 | Participants | ||
| Tube Retention | Pivotal Cohort | 206 | Participants | ||
| Anesthesia Effectiveness | Pivotal Cohort | 206 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pivotal Cohort | 241 | |
| Overall Study | STARTED | Office Lead-In Cohort | 59 | |
| Overall Study | STARTED | OR Lead-In Cohort | 70 | |
| Overall Study | Treated | Pivotal Cohort | 222 | |
| Overall Study | Treated | Office Lead-In Cohort | 47 | |
| Overall Study | Treated | OR Lead-In Cohort | 68 | |
| Overall Study | COMPLETED | Pivotal Cohort | 222 | |
| Overall Study | COMPLETED | Office Lead-In Cohort | 47 | |
| Overall Study | COMPLETED | OR Lead-In Cohort | 68 | |
| Overall Study | NOT COMPLETED | Pivotal Cohort | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Inadequate Anesthesia | Ear and labyrinth disorders | OR Lead-In Cohort (Subjects Treated in OR) | 0 | 68 | 0 |
| other | Inadequate Anesthesia | Ear and labyrinth disorders | Office Lead-In Cohort (Subjects Treated in Office) | 4 | 47 | 4 |
| other | Inadequate Anesthesia | Ear and labyrinth disorders | Pivotal Cohort (Subjects Treated in Office) | 8 | 222 | 8 |
| other | Occluded Tube | Ear and labyrinth disorders | OR Lead-In Cohort (Subjects Treated in OR) | 13 | 68 | 15 |
| other | Occluded Tube | Ear and labyrinth disorders | Office Lead-In Cohort (Subjects Treated in Office) | 5 | 47 | 6 |
| other | Occluded Tube | Ear and labyrinth disorders | Pivotal Cohort (Subjects Treated in Office) | 51 | 222 | 65 |
| other | Otorrhea | Ear and labyrinth disorders | OR Lead-In Cohort (Subjects Treated in OR) | 19 | 68 | 29 |
| other | Otorrhea | Ear and labyrinth disorders | Office Lead-In Cohort (Subjects Treated in Office) | 7 | 47 | 14 |
| other | Otorrhea | Ear and labyrinth disorders | Pivotal Cohort (Subjects Treated in Office) | 60 | 222 | 97 |
| other | Ear Pain | Ear and labyrinth disorders | OR Lead-In Cohort (Subjects Treated in OR) | 6 | 68 | 6 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OR Lead-In Cohort (Subjects Treated in OR) | 0 | 68 |
| Total, all-cause mortality | Office Lead-In Cohort (Subjects Treated in Office) | 0 | 47 |
| Total, all-cause mortality | Pivotal Cohort (Subjects Treated in Office) | 0 | 222 |
| Total, other adverse events | OR Lead-In Cohort (Subjects Treated in OR) | 28 | 68 |
| Total, other adverse events | Office Lead-In Cohort (Subjects Treated in Office) | 22 | 47 |
| Total, other adverse events | Pivotal Cohort (Subjects Treated in Office) | 79 | 222 |
| Total, serious adverse events | OR Lead-In Cohort (Subjects Treated in OR) | 4 | 68 |
| Total, serious adverse events | Office Lead-In Cohort (Subjects Treated in Office) | 0 | 47 |
| Total, serious adverse events | Pivotal Cohort (Subjects Treated in Office) | 3 | 222 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pivotal Cohort (6 Month to <5 Year Old Children) vs Pivotal Cohort (5 Through 12 Year Old Children): Procedural Success: |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03323736
GET https://conductscience.org/api/trials/v1/NCT03323736/events?page=2