Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
NCT ID: NCT01525849
Last Updated: 2017-02-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
151 participants
INTERVENTIONAL
2011-12-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
NCT01612780
Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
NCT04645511
Minimally Invasive Sinus Lift Through the Interradicular Septum
NCT05237570
XprESS Maxillary Balloon Dilation Study
NCT01525862
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
NCT02880514
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Balloon Sinus Dilation
XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment
Balloon Sinus Dilation
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Functional Endoscopic Sinus Surgery
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Functional Endoscopic Sinus Surgery
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Balloon Sinus Dilation
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Functional Endoscopic Sinus Surgery
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* maxillary sinus disease
* chronic sinusitis
Exclusion Criteria
* Samter's triad
* hemophilia
* prior sinus surgery
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Entellus Medical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Entellus Medical
Plymouth, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1984-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.