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

Integra LifeSciences

Status: Completed

Conditions: Chronic Sinusitis

Treatments: Device: Relieva™ Balloon Sinuplasty™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939471

CPR01918

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Relieva™ Balloon Sinuplasty™ System

Other group

Description:

Balloon Dilation of sinus ostium

Treatment:

Device: Relieva™ Balloon Sinuplasty™ System