Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 1:39 AM
Study NCT ID:
NCT03304951
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2017-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
Sponsor:
Sinopsys Surgical
Organization:
Study Overview
Official Title:
Interventioanl Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.
Detailed Description:
The primary objective of this study is to evaluate the safety and performance of the Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic antibiotic/steroid drug.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: