Chronic Sinusitis Clinical Trial
Official title:
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
The purpose of this study is to assess the safety and efficacy of the Propel mometasone
furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients
with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing
function within the sinus anatomy to separate mucosal tissues, provide stabilization of the
middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated
with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post
surgical inflammation within the supported tissues.
The study utilizes an intra-patient control design to assess the safety and efficacy of the
drug-coated implant compared to the non-drug coated implant that is identical in appearance.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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| Withdrawn |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 |