NCT00231062Phase 3Completed

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

Study sponsor: Integra LifeSciences Corporation

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2006-06Actual

Enrollment · participants115Actual

Source updated2024-08-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied: Chronic Sinusitis
Treatments or interventions studied: Not recorded
Primary outcomes · main study measures: Read the study measures
measure: Number of Sinuses With Patency of Sinus Ostium After Sinuplasty; description: Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.; timeFrame: 24 weeks; measure: Number of Participants With Adverse Events Following Sinuplasty Procedure; description: Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).; timeFrame: 24 weeks
History coverage: Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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