Clinical trials: Sinus Tract
Sinusitis
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal…
- Trial name
- NCT03390257
- Testing
- 3NT flexible endoscope
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- 3NT Medical Ltd.
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
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 With Nasal Polyps and Eosinophilia
Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.
- Trial name
- CS201 (NCT02217332)
- Testing
- dexpramipexole
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Knopp Biosciences
Sinusitis
BAY12-8039: 5 Days for Sinusitis vs Placebo
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief.
- Trial name
- NCT00492024
- Testing
- Moxifloxacin (Avelox, BAY12-8039)
- Where
- 51 sites in United States
- Volunteers
- 374 people
- Sponsor
- Bayer
Rhinosinusitis
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.
- Trial name
- NCT04123405
- Testing
- acetylcysteine
- Where
- 37 sites in Bulgaria, Germany and 2 more
- Volunteers
- 944 people
- Sponsor
- Sandoz
Allergic Fungal Rhinosinusitis
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
Primary Objective: To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: To evaluate the efficacy of treatment with…
- Trial name
- AIMS (NCT04684524)
- Testing
- Dupilumab SAR231893
- Where
- 47 sites in United States, Argentina and 7 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sanofi
Sinusitis, Bacterial Infections
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
- Trial name
- NCT00493038
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Amoxicillin/Clavulanate
- Where
- 34 sites in Italy
- Volunteers
- 293 people
- Sponsor
- Bayer
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
Rhinosinusitis
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
- Trial name
- RELIEF (NCT00986830)
- Testing
- FinESS Sinus Treatment
- Where
- 13 sites in United States
- Volunteers
- 74 people
- Sponsor
- Entellus Medical, Inc.
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
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
Sinusitis
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
- Trial name
- MERLOT (NCT01685229)
- Testing
- Balloon sinus dilation, Medical Management
- Where
- 20 sites in United States
- Volunteers
- 198 people
- Sponsor
- Integra LifeSciences Corporation
Pulmonary Disease, Chronic Obstructive, Bronchospasm
Prophylactic Efficacy of Relenza Against Influenza A and B
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchospasm, Influenza, Human, Asthma
- Trial name
- NCT01156701
- Testing
- Receiving a prescription of Relenza for prophylaxis, No prophylaxis with Relenza
- Volunteers
- 171,705 people
- Sponsor
- GlaxoSmithKline
Nasal Congestion, Respiratory Tract Infection
Home Usability of a Nasal Lavage System in Children
This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription.
- Conditions
- Nasal Congestion, Respiratory Tract Infection, Sinusitis, Allergic Rhinitis
- Trial name
- NCT01129765
- Testing
- Use of an automatic nasal irrigator/aspirator
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Aardvark Medical Company
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
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, 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
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.