Tympanostomy Tube Placement in Children in the Office (Inova Study)

Otitis Media Clinical Trial

— Inova  

Official title:

Tympanostomy Tube Placement in Children in the Office (Inova Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496287
• Other study ID #: CPR005027
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: November 4, 2014
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2014
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 21 Years

Eligibility

Inclusion Criteria:

1. Scheduled to undergo tympanostomy tube insertion

2. At least 6 months old and younger than 22 years old

3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

4. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

1. Pregnant or lactating females

2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane

3. Otitis externa

4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal

5. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

6. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)

7. Anatomy that precludes sufficient visualization of and access to the tympanic membrane

8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis Media

Intervention

Device:
• Tube Delivery System (TDS)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Locations

Country	Name	City	State
United States	South Coast Ear, Nose & Throat	Port St. Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Procedural, Serious, and Device-Related Adverse Events	Adverse events which are procedural, serious, and device-related.	procedure up to 2 weeks post procedure	Yes
Primary	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.	Day 0 (day of procedure)	No
Secondary	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.	Day 0 (day of procedure)	No
Secondary	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"	Day 0 (day of procedure)	No
Secondary	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.	2 weeks post procedure	No