Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)
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ClinicalTrials.gov Identifier: NCT00939471 |
Recruitment Status :
Completed
First Posted : July 15, 2009
Results First Posted : August 17, 2012
Last Update Posted : September 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Sinusitis | Device: Relieva™ Balloon Sinuplasty™ System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | N/A |
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 |
Arm | Intervention/treatment |
---|---|
Relieva™ Balloon Sinuplasty™ System
Balloon Dilation of sinus ostium
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Device: Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other Name: Relieva |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Revision Rate [ Time Frame: at 1 year ]The number of subjects requiring revisions out of 33 subjects treated.

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 2 and < 18 years
- Both male and female patients eligible
- 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)
- Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Exclusion Criteria:
- Extensive previous sinonasal surgery in target ostia
- Cystic fibrosis
- Extensive sinonasal osteoneogenesis
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- For female patients of childbearing age: the patient is either pregnant or lactating

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939471
United States, West Virginia | |
West Virginia University | |
Morgantown, West Virginia, United States, 26506 |
Principal Investigator: | Hassan Ramadan, MD | West Virginia University |
Responsible Party: | Acclarent |
ClinicalTrials.gov Identifier: | NCT00939471 |
Other Study ID Numbers: |
CPR01918 |
First Posted: | July 15, 2009 Key Record Dates |
Results First Posted: | August 17, 2012 |
Last Update Posted: | September 5, 2017 |
Last Verified: | August 2017 |
Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |