Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)

NCT ID: NCT01714687

Last Updated: 2024-07-12

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2016-04-01

Brief Summary

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This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.

Detailed Description

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Conditions

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Recurrent Acute Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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balloon sinus dilation

Balloon sinus dilation will be conducted in-office under local anesthesia.

Group Type ACTIVE_COMPARATOR

balloon sinus dilation

Intervention Type DEVICE

medical therapy

Intervention Type OTHER

medical therapy

Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.

Group Type ACTIVE_COMPARATOR

medical therapy

Intervention Type OTHER

Interventions

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balloon sinus dilation

Intervention Type DEVICE

medical therapy

Intervention Type OTHER

Other Intervention Names

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balloon sinuplasty medical management

Eligibility Criteria

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Inclusion Criteria

* 19 years of age or greater
* diagnosis of recurrent acute rhinosinusitis
* suitable candidate for office-based procedure
* willing and able to read and sign informed consent and remain compliant with protocol and study procedures
* able to read and understand English

Exclusion Criteria

* diagnosis of chronic rhinosinusitis
* prior sinus surgery
* physician determined need for ancillary procedures
* known immune deficiency, ciliary dysfunction and/or autoimmune disease
* clinically significant illness that may interfere with evaluation of the study
* participation in clinical studies 6 months prior to study participation
* pregnant or lactating females
Minimum Eligible Age

19 Years

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

Principal Investigators

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Ashley Sikand, MD

Role: PRINCIPAL_INVESTIGATOR

Ear Nose and Throat Consultants of Nevada

Ford Albritton, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Institute for Sinus & Respiratory Disease

Locations

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Birmingham, Alabama, United States

Site Status

Atlanta, Georgia, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Dallas, Texas, United States

Site Status

McKinney, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CPR005030

Identifier Type: -

Identifier Source: org_study_id

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