inVENT-In-Office Study

NCT ID: NCT01324271

Last Updated: 2024-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Otitis Media

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tympanostomy tube placement

placement of tympanostomy tube under local anesthesia in office/clinic setting

Group Type EXPERIMENTAL

Acclarent Tympanostomy Tube Delivery system (TTDS)

Intervention Type DEVICE

placement of tympanostomy tube under local anesthesia

Interventions

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Acclarent Tympanostomy Tube Delivery system (TTDS)

placement of tympanostomy tube under local anesthesia

Intervention Type DEVICE

Other Intervention Names

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Tula™

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acclarent

INDUSTRY

Sponsor Role collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CPR005016

Identifier Type: -

Identifier Source: org_study_id

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