Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)
This study has been completed.
Sponsor:
Acclarent
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01202578
First received: September 13, 2010
Last updated: June 10, 2014
Last verified: June 2014
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Purpose
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
| Condition | Intervention | Phase |
|---|---|---|
|
Otitis Media With Effusion Acute Otitis Media |
Device: tympanostomy tube |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Acclarent:
Primary Outcome Measures:
- Safety of Tympanostomy Tube (TT) Delivery System [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Proportion of Subjects With Procedure Success [ Time Frame: 0 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
| Enrollment: | 53 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tympanostomy tube
performance and safety of tympanostomy tube delivery system
|
Device: tympanostomy tube
tympanostomy tube delivery system
|
Eligibility| Ages Eligible for Study: | 6 Months and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202578
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202578
Locations
| 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 | |
Sponsors and Collaborators
Acclarent
Investigators
| 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 |
More Information
| Responsible Party: | Acclarent |
| ClinicalTrials.gov Identifier: | NCT01202578 History of Changes |
| Other Study ID Numbers: | CPR005013 |
| Study First Received: | September 13, 2010 |
| Results First Received: | May 7, 2014 |
| Last Updated: | June 10, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Otitis Otitis Media Otitis Media with Effusion Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on September 30, 2016