Global Sinus Surgery Registry

Terminated

• Conditions: Recurrent Acute Rhinosinusitis; Chronic Rhinosinusitis

• Registration Number: NCT02347943
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Primary Completion: 2015-11-01
• Study Completion: 2015-11-01
• Results First Submitted: 2017-06-09
• Results First Submitted QC: 2018-10-17
• Results First Posted: 2019-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Age ≥ 18 years or minimum adult age as required by local regulations
• The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure
• Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines
• The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form
• Subject is able to read and understand local language

Exclusion Criteria

• Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions
• Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III
• Planned external approaches (i.e. not trans-nasal)
• Planned off-label usage of balloon sinus dilation products.
• Balloon sinus dilation performed with a non-Acclarent balloon product

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing Follow-Up Visits	2 years