Clinical trials: Sinusitis, Chronic
Chronic Sinusitis, Nasal Polyps
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
- Trial name
- RESOLVE (NCT01732536)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
A randomized controlled trial
- Trial name
- FRONTIER (NCT02880514)
- Testing
- PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone
- Where
- 9 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Intersect ENT
Chronic Sinusitis, Nasal Polyposis
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
- Trial name
- NCT03358329
- Testing
- S8 Sinus Implant
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
Balloon Sinus Dilation In Office or OR
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices.
- Trial name
- ORIOS (NCT00939393)
- Testing
- FESS instruments with or without balloon treatment, Balloon Sinuplasty
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Integra LifeSciences Corporation
Rhinosinusitis Chronic, Microbiome
Impact of Symbiofilm On Nasal Microbiota
Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%)…
- Trial name
- ISONAM (NCT05015530)
- Testing
- Healsea® Chronic, hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Lallemand Pharma AG
Rhinosinusitis, Chronic Polyposis
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with…
- Trial name
- NCT01946711
- Testing
- Budesonide
- Where
- 4 sites in Germany
- Volunteers
- 14 people
- Sponsor
- Pari Pharma GmbH
Chronic Sinusitis
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
- Trial name
- CONSENSUS II (NCT00840970)
- Testing
- non-coated Intranasal Splint, Sinexus Intranasal Splint
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus…
- Trial name
- EXCEED (NCT02228720)
- Testing
- Propel Nova Sinus Implant
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intersect ENT
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
- Trial name
- NCT04041609
- Testing
- LYR-210
- Where
- 22 sites in Australia, Austria and 3 more
- Volunteers
- 71 people
- Sponsor
- Lyra Therapeutics
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
- Trial name
- NCT05035654
- Testing
- LYR-220 Design 1 (Part 1 only), LYR-220 Design 2 (Part 1 and Part 2)
- Where
- 25 sites in United States, Australia
- Volunteers
- 48 people
- Sponsor
- Lyra Therapeutics
Sinusitis
Balloon REmodeling Antrostomy THErapy Study
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis.
- Trial name
- BREATHE I (NCT00645762)
- Testing
- RS-Series Rhinosinusitis Treatment System, FinESS Balloon
- Where
- 13 sites in United States
- Volunteers
- 71 people
- Sponsor
- Entellus Medical, Inc.
Chronic Sinusitis With or Without Nasal Polyps
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or…
- Trial name
- NCT01623323
- Testing
- Fluticasone Propionate
- Where
- 18 sites in United States
- Volunteers
- 705 people
- Sponsor
- Optinose US Inc.
Sinusitis
Sinus Balloon Dilation in Pediatric Patients
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
- Trial name
- NCT02278484
- Testing
- XprESS device and PathAssist confirmation tools
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Entellus Medical, Inc.
Acute Rhinosinusitis, Recurrent Acute Rhinosinusitis
NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
N-acetylcysteine (NAC), known to have mucolytic and antioxidant effects, is widely used to treat respiratory diseases and manage post-surgery pulmonary complications.
- Conditions
- Acute Rhinosinusitis, Recurrent Acute Rhinosinusitis, Chronic Rhinosinusitis
- Trial name
- NOTUS (NCT04131686)
- Where
- South Korea
- Volunteers
- 294 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Sinusitis, Chronic Rhinosinusitis
Clinical Evaluation of the Ethmoid Sinus Spacer
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
- Trial name
- SPACER (NCT01054703)
- Testing
- Ethmoid Sinus Spacer
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Integra LifeSciences Corporation
Chronic Sinusitis
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
- Trial name
- NCT00231062
- Testing
- Sinuplasty
- Volunteers
- 115 people
- Sponsor
- Integra LifeSciences Corporation
Chronic Sinusitis, Nasal Polyposis
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
- Trial name
- RESOLVE_II (NCT02291549)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus…
- Trial name
- NCT00912405
- Testing
- Steroid-Eluting Sinexus Intranasal Splint
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Rhinosinusitis
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
The study should create data for the selection of a clinically relevant endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.
- Trial name
- NCT01955980
- Testing
- Budesonide
- Where
- 3 sites in Germany
- Volunteers
- 19 people
- Sponsor
- Pari Pharma GmbH
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
XprESS Maxillary Balloon Dilation Study
A prospective, single-arm, post approval pilot study.
- Trial name
- NCT01525862
- Testing
- Balloon sinus dilation
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Entellus Medical, Inc.