Clinical Study of the Tympanostomy Tube Delivery System
inVENT
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)
1 other identifier
interventional
16
1 country
2
Brief Summary
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
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 Mar 2009
Shorter than P25 for not_applicable
2 active sites
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
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedResults Posted
Study results publicly available
June 9, 2014
CompletedAugust 6, 2024
July 1, 2024
3 months
July 14, 2009
May 7, 2014
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Device Success
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
At procedure visit
Secondary Outcomes (2)
Cross-Over to Manual Myringotomy and Tube Placement
at procedure visit
Tube Retention
two weeks post-procedure
Study Arms (1)
Tympanostomy Tube Delivery System (TTDS)
EXPERIMENTALTympanostomy tube placement with Acclarent tube delivery system
Interventions
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
Eligibility Criteria
You may qualify if:
- Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- Either male or female
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
- Stenosed ear canal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
Study Sites (2)
Bay Area ENT
Biloxi, Mississippi, 39532, United States
Ear Medical Group
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Acclarent
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Syms, III, MD
Ear Medical Group
- PRINCIPAL INVESTIGATOR
Charles Wilson, MD
Bay Area ENT
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
July 14, 2009
First Posted
July 15, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
August 6, 2024
Results First Posted
June 9, 2014
Record last verified: 2024-07