N/A
Completed N=85
inVENT-In-Office Study
Source: ClinicalTrials.gov NCT01324271 ↗Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Subjects With In-office Tube Placement Procedure Success — 93.2 Percentage of Subjects
Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With In-office Tube Placement Procedure Success |
93.2 | — |
| PRIMARY Percentage of Tubes Successfully Placed Using a TTDS Device |
82.2 | — |
| SECONDARY Number of Retained (TTDS-placed) Tubes |
74 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old
- Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
Exclusion Criteria
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Anatomy that precludes sufficient visualization of and access to the tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Data sourced from ClinicalTrials.gov (NCT01324271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.