CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
Sinuplastydevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓Chronic sinusitis not responding to medical management
  • ✓Candidate for endoscopic sinus surgery as recommended by investigator and consented to by patient
Key exclusion· 9
  • ✕Extensive sinonasal polyps
  • ✕Extensive previous sinonasal surgery
  • ✕Extensive sinonasal osteoneogenesis
  • ✕Cystic fibrosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00231062
NCT00231062Phase 3Completed
CompareCT.gov

Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

Integra LifeSciences Corporation·interventional·Posted Oct 4, 2005·Updated Aug 6, 2024

In Brief

A Phase 3 clinical trial evaluating Sinuplasty for Chronic Sinusitis. Completed, enrolled 115 participants.

Detailed Summary

A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis
Countries--
CollaboratorsAcclarent

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.7 years ago

Interventions

Sinuplastydevice