At a glance
ClinicalIndex Comparison RecordN/ACompleted· 44 enrolled
Drug / intervention
Relieva™ Balloon Sinuplasty™ Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
In Brief
A clinical study evaluating Relieva™ Balloon Sinuplasty™ System for Chronic Sinusitis. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis
CountriesUnited States
CollaboratorsAcclarent
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
Primary CompletionJul 2009
First PostedJul 2009
Study CompletionMay 2010
TodayJul 2026
First PostedJul 15, 2009
Enrollment StartApr 1, 2007
Primary CompletionJul 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.0 years ago
Interventions
Relieva™ Balloon Sinuplasty™ Systemdevice
Balloon dilation will be performed using endoscopic equipment with video documentation capability.