Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
1 other identifier
interventional
115
0 countries
N/A
Brief Summary
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedResults Posted
Study results publicly available
July 8, 2011
CompletedAugust 6, 2024
July 1, 2024
1.2 years
September 30, 2005
April 29, 2011
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
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.
24 weeks
Number of Participants With Adverse Events Following Sinuplasty Procedure
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).
24 weeks
Secondary Outcomes (1)
Number of Participants Experiencing Relief of Sinus Symptoms
Week 24
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years and greater
- Both male and female patients eligible
- Diagnosis of chronic sinusitis that is not responsive to medical management
- Planned endoscopic sinus surgery (recommended by PI, consented to by patient)
You may not qualify if:
- Extensive sinonasal polyps
- Extensive previous sinonasal surgery
- Extensive sinonasal osteoneogenesis
- Cystic fibrosis
- Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- Pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura England, Manager-Clinical Affairs
- Organization
- Acclarent
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Church, MD
Loma Linda University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
April 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
August 6, 2024
Results First Posted
July 8, 2011
Record last verified: 2024-07