NCT01202578Phase 2, phase 3Completed

Evaluation of the Tympanostomy Tube Delivery System

Study sponsor: Integra LifeSciences Corporation

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2010-11Actual

Enrollment · participants53Actual

Source updated2024-08-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Otitis Media With Effusion; Acute Otitis Media

Treatments or interventions studied

Not recorded

Primary outcomes · main study measures

Read the study measures

measure: Safety of Tympanostomy Tube (TT) Delivery System; description: 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.; timeFrame: 7 days; measure: Device Success; description: 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.; timeFrame: 0 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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