inVENT-In-Office Study (inVENT-IO)

December 8, 2014 updated by: Acclarent

A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled to undergo tympanostomy tube insertion
  • At least 6 months old
  • Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

Exclusion Criteria:

  • History of sensitivity or reaction to anesthesia chosen for the procedure
  • Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
  • Otitis externa
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tympanostomy tube placement
placement of tympanostomy tube under local anesthesia in office/clinic setting
Device: Acclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia
Other Names:
  • Tula™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With In-office Tube Placement Procedure Success
Time Frame: Day 0
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: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Day 0
Percentage of Tubes Successfully Placed Using a TTDS Device
Time Frame: Day 0

Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.

A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Retained (TTDS-placed) Tubes
Time Frame: 14 days
Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acclarent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR005016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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