Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)
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ClinicalTrials.gov Identifier: NCT01202578 |
Recruitment Status
:
Completed
First Posted
: September 16, 2010
Results First Posted
: July 11, 2014
Last Update Posted
: July 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Otitis Media With Effusion Acute Otitis Media | Device: tympanostomy tube | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: tympanostomy tube
performance and safety of tympanostomy tube delivery system
|
Device: tympanostomy tube
tympanostomy tube delivery system
|
- Safety of Tympanostomy Tube (TT) Delivery System [ Time Frame: 7 days ]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.
- Device Success [ Time Frame: 0 days ]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.
- Proportion of Subjects With Procedure Success [ Time Frame: 0 days ]Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
- Tube Retention [ Time Frame: 7 days ]Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.

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Ages Eligible for Study: | 6 Months and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
Exclusion Criteria:
- Reaction to anesthesia
- Markedly atrophic, 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 visualization and access to tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202578
United States, Florida | |
South Coast ENT | |
Port St. Lucie, Florida, United States, 34952 | |
United States, Kentucky | |
Advanced ENT and Allergy | |
Louisville, Kentucky, United States, 40207 | |
United States, Texas | |
Ear Medical Group | |
San Antonio, Texas, United States, 78240 | |
United States, Washington | |
Evergreen Sinus Center | |
Kirkland, Washington, United States, 98034 |
Principal Investigator: | Kenneth Faw, MD | Evergreen Sinus Center | |
Principal Investigator: | Andrew Gould, MD | Advanced ENT and Allergy | |
Principal Investigator: | Charles Syms, MD | Ear Medical Group | |
Principal Investigator: | Jacob Zeiders, MD | South Coast ENT |
Responsible Party: | Acclarent |
ClinicalTrials.gov Identifier: | NCT01202578 History of Changes |
Other Study ID Numbers: |
CPR005013 |
First Posted: | September 16, 2010 Key Record Dates |
Results First Posted: | July 11, 2014 |
Last Update Posted: | July 11, 2014 |
Last Verified: | June 2014 |
Additional relevant MeSH terms:
Otitis Otitis Media Otitis Media with Effusion Ear Diseases Otorhinolaryngologic Diseases |