Clinical trials: Sinus Infection
Sinusitis
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS).
- Trial name
- ORIOS 2 (NCT01107379)
- Testing
- Relieva Balloon Sinuplasty System
- Where
- 3 sites in United States
- Volunteers
- 203 people
- Sponsor
- Integra LifeSciences Corporation
Sinusitis
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
- Trial name
- NCT01623050
- Testing
- SinuSys Dilation System
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- SinuSys Corporation
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
Common Cold
Testing the Efficacy in Adults With Cold of HEalsea Rescue*
Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria.
- Trial name
- TEACHER (NCT05819190)
- Testing
- Healsea Rescue*
- Where
- Bulgaria
- Volunteers
- 200 people
- Sponsor
- Lallemand Pharma AG
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
Sinusitis, Acute
Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with…
- Trial name
- NCT01018030
- Testing
- FFNS 110 mcg QD, FFNS 110 mcg BID
- Where
- 87 sites in Bulgaria, Canada and 10 more
- Volunteers
- 741 people
- Sponsor
- GlaxoSmithKline
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 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
Sinusitis
XprESS Registry Study
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
- Trial name
- NCT01115309
- Testing
- XprESS Balloon Device
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Entellus Medical, Inc.
Maxillary Sinusitis
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the…
- Trial name
- EASY (NCT01032174)
- Testing
- Azithromycin SR, Amoxiclav 1000 mg
- Volunteers
- 123 people
- Sponsor
- Pfizer
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
Hidradenitis Suppurativa
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
- Trial name
- NCT00918255
- Testing
- adalimumab
- Where
- 26 sites in United States, Denmark and 2 more
- Volunteers
- 154 people
- Sponsor
- Abbott
Sinusitis
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
- Trial name
- NCT01612780
- Testing
- XprESS Multi-Sinus Dilation Tool
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Entellus Medical, Inc.
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.