Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Chronic Sinusitis Clinical Trial

— INTACT  

Official title:

Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939471
• Other study ID #: CPR01918
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: July 10, 2012
• Start date: April 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months	Number of device-related adverse events from time of procedure through 12 months post-procedure.	12 months	Yes
Primary	Effectiveness: Change in Sinus Symptom Scores (SN-5)	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.	12 months	No
Primary	Effectiveness: Change in Sinus Symptom Scores (SNOT-20)	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.	12 months	No
Secondary	Device Success: Ability to Access/Dilate Sinus Ostia	Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.	12 months	No
Secondary	Effectiveness: Medication Thru 1 yr	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.	12 months	No
Secondary	Effectiveness of Dilation/Measured by Post-op Interventions	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.	12 months	Yes
Secondary	Days Out of School During the 12 Months of Follow-up	Quantitative assessment of days out of school during the 12 months of follow-up.	12 months	No
Secondary	Revision Rate	The number of subjects requiring revisions out of 33 subjects treated.	at 1 year	No