Back to resultsTympanostomy Tube Placement in Children in the Office (Inova Study) (Inova)
Primary Purpose
Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tube Delivery System (TDS)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old and younger than 22 years 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
Sites / Locations
- South Coast Ear, Nose & Throat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tube placement group
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Adverse events which are procedural, serious, and device-related.
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
Secondary Outcome Measures
Procedure Success
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.
Procedure Tolerability
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"
Tube Retention
Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01496287
Brief Title
Tympanostomy Tube Placement in Children in the Office (Inova Study)
Acronym
Inova
Official Title
Tympanostomy Tube Placement in Children in the Office (Inova Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acclarent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tube placement group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tube Delivery System (TDS)
Other Intervention Name(s)
Tula TDS
Intervention Description
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Primary Outcome Measure Information:
Title
Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Description
Adverse events which are procedural, serious, and device-related.
Time Frame
procedure up to 2 weeks post procedure
Title
Device Success
Description
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
Time Frame
Day 0 (day of procedure)
Secondary Outcome Measure Information:
Title
Procedure Success
Description
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.
Time Frame
Day 0 (day of procedure)
Title
Procedure Tolerability
Description
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"
Time Frame
Day 0 (day of procedure)
Title
Tube Retention
Description
Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
Time Frame
2 weeks post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo tympanostomy tube insertion
At least 6 months old and younger than 22 years 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob W Zeiders, M.D.
Organizational Affiliation
South Coast Ear, Nose & Throat
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Coast Ear, Nose & Throat
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26611339
Citation
Zeiders JW, Syms CA, Mitskavich MT, Yen DM, Harfe DT, Shields RD, Lanier BJ, Gould AR, Mouzakes J, Elliott CL. Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2416-23. doi: 10.1016/j.ijporl.2015.11.003. Epub 2015 Nov 10.
Results Reference
derived
PubMed Identifier
26514928
Citation
Cohen LL, Martin SR, Gamwell KL, McCarty C, Shih SW. Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2170-3. doi: 10.1016/j.ijporl.2015.09.041. Epub 2015 Oct 8.
Results Reference
derived
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Tympanostomy Tube Placement in Children in the Office (Inova Study)
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