Status:
COMPLETED
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
2-17 years
Phase:
NA
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 faile...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00939471
Start Date
April 1 2007
End Date
May 1 2010
Last Update
July 12 2024
Active Locations (1)
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1
West Virginia University
Morgantown, West Virginia, United States, 26506