Clinical trials: Maxillary Sinusitis
Chronic Sinusitis
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative…
- Trial name
- REMODEL (NCT01525849)
- Testing
- Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
- Where
- United States
- Volunteers
- 151 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.
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.
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
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
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)
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.