Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
inVENT2
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
1 other identifier
interventional
29
1 country
1
Brief Summary
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedJuly 12, 2024
July 1, 2024
8 months
May 27, 2014
June 26, 2014
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Ear Outcome Success
Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Day 0 (at procedure visit)
Secondary Outcomes (2)
Procedure Success
Day 0 (at procedure visit)
Tube Retention
1 week
Study Arms (1)
Tympanostomy tube
EXPERIMENTALPerformance and safety of tympanostomy tube delivery system
Interventions
tympanostomy tube delivery system
Eligibility Criteria
You may qualify if:
- Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
You may not qualify if:
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology requiring T-tubes
- Stenosed ear canal
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
Study Sites (1)
Unknown Facility
Kirkland, Washington, 98034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Acclarent, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
May 29, 2014
Study Start
February 1, 2010
Primary Completion
October 1, 2010
Study Completion
November 1, 2010
Last Updated
July 12, 2024
Results First Posted
September 25, 2014
Record last verified: 2024-07