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

NCT01714687 | Completed Results FDA Device

• 1 other identifier: CPR005030
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Recurrent Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• CSS Total Score Change From Baseline to 24 Week Visit

  The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.

  24 Week Visit

Secondary Outcomes (8)

• CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks

  8, 16, 24, 32, 40, and 48 Weeks

• RSDI Total and Sub-score Changes From Baseline Over 48 Weeks

  8, 24, and 48 Weeks

• Medication Usage at 24 and 48 Weeks

  24 Weeks and 48 Weeks

• Unscheduled Medical Care Visits Due to Sinusitis

  24 Weeks and 48 Weeks

• Sinus Infections and Sinus Severity - Part 1

  24 Weeks and 48 Weeks

Study Arms (2)

balloon sinus dilation

ACTIVE COMPARATOR

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

Device: balloon sinus dilation; Other: medical therapy

medical therapy

ACTIVE COMPARATOR

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

Other: medical therapy

Interventions

balloon sinus dilation DEVICE

Also known as: balloon sinuplasty

balloon sinus dilation

medical therapy OTHER

Also known as: medical management

balloon sinus dilation; medical therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (5)

Unknown Facility

Birmingham, Alabama, 35242, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Las Vegas, Nevada, 89113, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

McKinney, Texas, 75070, United States

Location

MeSH Terms

Interventions

Nutrition Therapy; Practice Management, Medical

Intervention Hierarchy (Ancestors)

Therapeutics; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Patricia Chen
• Organization: Acclarent, Inc

pchen126@its.jnj.com

949-453-6408

Study Officials

• Ashley Sikand, MD

  Ear Nose and Throat Consultants of Nevada

  PRINCIPAL INVESTIGATOR

• Ford Albritton, MD

  Texas Institute for Sinus & Respiratory Disease

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 12, 2024
• Results First Posted: March 11, 2019

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (5)