Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.

Condition or disease	Intervention/treatment	Phase
Chronic Sinusitis	Device: Relieva™ Balloon Sinuplasty™ System	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
Actual Study Start Date :	April 1, 2007
Actual Primary Completion Date :	July 1, 2009
Actual Study Completion Date :	May 1, 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Relieva™ Balloon Sinuplasty™ System; Balloon Dilation of sinus ostium	Device: Relieva™ Balloon Sinuplasty™ System; Balloon dilation will be performed using endoscopic equipment with video documentation capability.; Other Name: Relieva

Outcome Measures

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Primary Outcome Measures :

1. Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months [ Time Frame: 12 months ]
   Number of device-related adverse events from time of procedure through 12 months post-procedure.
2. Effectiveness: Change in Sinus Symptom Scores (SN-5) [ Time Frame: 12 months ]
   Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
3. Effectiveness: Change in Sinus Symptom Scores (SNOT-20) [ Time Frame: 12 months ]
   Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.

Secondary Outcome Measures :

1. Device Success: Ability to Access/Dilate Sinus Ostia [ Time Frame: 12 months ]
   Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
2. Effectiveness: Medication Thru 1 yr [ Time Frame: 12 months ]
   Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.
3. Effectiveness of Dilation/Measured by Post-op Interventions [ Time Frame: 12 months ]
   Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.
4. Days Out of School During the 12 Months of Follow-up [ Time Frame: 12 months ]
   Quantitative assessment of days out of school during the 12 months of follow-up.
5. Revision Rate [ Time Frame: at 1 year ]
   The number of subjects requiring revisions out of 33 subjects treated.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Age > 2 and < 18 years
2. Both male and female patients eligible
3. Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
4. Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan

Exclusion Criteria:

1. Extensive previous sinonasal surgery in target ostia
2. Cystic fibrosis
3. Extensive sinonasal osteoneogenesis
4. Sinonasal tumors or obstructive lesions
5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
6. Ciliary dysfunction
7. For female patients of childbearing age: the patient is either pregnant or lactating

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Acclarent

Investigators

Principal Investigator:	Hassan Ramadan, MD	West Virginia University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Acclarent
ClinicalTrials.gov Identifier:	NCT00939471 History of Changes
Other Study ID Numbers:	CPR01918
First Posted:	July 15, 2009
Results First Posted:	August 17, 2012
Last Update Posted:	September 5, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Sinusitis; Paranasal Sinus Diseases; Nose Diseases	Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases