Clinical Trials Logo

Clinical Trial Summary

The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.


Clinical Trial Description

The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01894503
Study type Interventional
Source Intersect ENT
Contact
Status Completed
Phase Phase 2
Start date June 2013
Completion date October 2013

See also
  Status Clinical Trial Phase
Completed NCT02266810 - Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus Phase 3
Completed NCT01706484 - Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis Phase 3
Completed NCT01197612 - Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis Phase 3
Completed NCT04163978 - Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) Phase 2
Completed NCT04418622 - Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
Not yet recruiting NCT06070311 - Wound Healing After Endoscopic Sinus Surgery N/A
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Withdrawn NCT01185808 - Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps N/A
Completed NCT01700725 - Gulf War Illness Nasal Irrigation Study Phase 2
Withdrawn NCT00671281 - The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery N/A
Completed NCT00447837 - Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis Phase 2
Recruiting NCT04362501 - Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Phase 2
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Completed NCT02562924 - The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery N/A
Completed NCT01007799 - Vitamin D for Chronic Sinusitis N/A
Completed NCT03358329 - Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) Phase 3
Withdrawn NCT02981017 - Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure N/A
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Recruiting NCT01854619 - Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis N/A
Completed NCT00924404 - Xylitol Versus Saline in Chronic Sinusitis N/A