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

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Device: Tube Delivery System (TDS)

• Registration Number: NCT01496287
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2014-06-26
• Results First Submitted QC: 2014-06-26
• Results First Posted: 2014-07-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tube placement group	Tube Delivery System (TDS)	-

Primary Outcome Measures

Name	Time	Method
Device Success	Day 0 (day of procedure)	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.
Number of Participants With Procedural, Serious, and Device-Related Adverse Events	procedure up to 2 weeks post procedure	Adverse events which are procedural, serious, and device-related.

Secondary Outcome Measures

Name	Time	Method
Procedure Success	Day 0 (day of procedure)	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.
Tube Retention	2 weeks post procedure	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.
Procedure Tolerability	Day 0 (day of procedure)	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"

Trial Locations

Locations (1)

South Coast Ear, Nose & Throat; 🇺🇸 Port Saint Lucie, Florida, United States