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

• ClinicalTrials.gov Identifier: NCT00939471
• Recruitment Status: Completed
• First Posted: July 15, 2009
• Results First Posted: August 17, 2012
• Last Update Posted: September 5, 2017
• Sponsor: Acclarent
• Information provided by (Responsible Party): Acclarent

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

• Responsible Party: Acclarent
• ClinicalTrials.gov Identifier: NCT00939471
• 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