Global Sinus Surgery Registry

Chronic Rhinosinusitis Clinical Trial

— OASIS  

Official title:

OASIS Global Sinus Surgery Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02347943
• Other study ID #: CPR005044
• Status: Terminated
• Start date: January 1, 2015
• Est. completion date: November 1, 2015

Study information

• Verified date: February 2019
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 252
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Recurrent Acute Rhinosinusitis
• Sinusitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Completing Follow-Up Visits		2 years