N/A
N=42
inVENT-visIOn Study
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01444391 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Sep 2014
Primary outcome: Primary: Number of Subjects With Procedural, Serious and Device-related Adverse Events. — 0 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tympanostomy tube placement (Acclarent iontophoresis device) (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Procedural, Serious and Device-related Adverse Events. |
— | — |
| PRIMARY Device Success |
55 | — |
| SECONDARY Procedure Success |
42 | — |
| SECONDARY Procedure Tolerability |
36 | — |
| SECONDARY Tube Retention |
52 | — |
Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.
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)
- No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion Criteria
- Pregnant or lactating females
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- 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 (NCT01444391). 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.