Comparison · NCT03323736-6ca63da2
Pivotal Cohort (6 Month to <5 Year Old Children) vs Pivotal Cohort (5 Through 12 Year Old Children): Procedural Success:
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pivotal Cohort (6 Month to <5 Year Old Children) vs Pivotal Cohort (5 Through 12 Year Old Children): Procedural Success:. Trial comparisons, record NCT03323736-6ca63da2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03323736-6ca63da2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.858 | 0.785 | 0.91 | wilson | |
| Risk in group 2 | 0.892 | 0.817 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0338 | -0.121 | 0.0571 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.962 | 0.871 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.732 | 0.326 | 1.64 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pivotal Cohort (6 Month to <5 Year Old Children) than on Pivotal Cohort (5 Through 12 Year Old Children) | 29.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pivotal Cohort (6 Month to <5 Year Old Children) | Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis \& 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. | 103 | 120 | OG000 |
| Group 2 | Pivotal Cohort (5 Through 12 Year Old Children) | Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis \& 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. | 91 | 102 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Procedural Success:
- Description
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
- Population
Source ClinicalTrials.gov
Trial
- Title
- In-Office Tympanostomy Tube Placement in Children (OTTER)
- NCT number
- NCT03323736
- Phases
- PHASE3
- Conditions
- OME - Otitis Media With Effusion, AOM - Acute Otitis Media
- Interventions
- Iontophoresis & tube placement, Tube placement
- Lead sponsor
- Tusker Medical
- Results first posted
- 2020-01-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03323736?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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