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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Acclarent

ClinicalTrials.gov Identifier:

NCT01496287

First received: December 16, 2011

Last updated: November 4, 2014

Last verified: November 2014

History of Changes

Results First Received: June 26, 2014

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Otitis Media
Intervention:	Device: Tube Delivery System (TDS)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Tube Placement Group	Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device

Participant Flow: Overall Study

	Tube Placement Group
STARTED	70
COMPLETED	64
NOT COMPLETED	6
Lost to Follow-up	1
Incomplete anesthesia	5

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

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

Baseline Measures

	Tube Placement Group
Overall Participants Analyzed [Units: Participants]	70

Age [Units: Years] Mean (Standard Deviation)	7.0 (3.9)

Gender [Units: Participants]
Female	36
Male	34

Race/Ethnicity, Customized [Units: Participants]
African American or Black	5
Asian	1
White	47
Other or Unknown	17

Region of Enrollment [Units: Participants]
United States	70

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Procedural, Serious, and Device-Related Adverse Events [ Time Frame: procedure up to 2 weeks post procedure ]

Show Outcome Measure 1

2. Primary:

Device Success [ Time Frame: Day 0 (day of procedure) ]

Show Outcome Measure 2

3. Secondary:

Procedure Success [ Time Frame: Day 0 (day of procedure) ]

Show Outcome Measure 3

4. Secondary:

Procedure Tolerability [ Time Frame: Day 0 (day of procedure) ]

Show Outcome Measure 4

5. Secondary:

Tube Retention [ Time Frame: 2 weeks post procedure ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Director of Clinical Research
Organization: Acclarent, Inc.
phone: 650-687-5888
e-mail: lenglan1@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Acclarent
ClinicalTrials.gov Identifier:	NCT01496287 History of Changes
Other Study ID Numbers:	CPR005027
Study First Received:	December 16, 2011
Results First Received:	June 26, 2014
Last Updated:	November 4, 2014

To Top