Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to evaluate the efficacy of PROPEL Contour Sinus Implant placement in the frontal sinus ostia following dilation in patients with chronic rhinosinusitis (CRS)


Clinical Trial Description

A prospective, randomized, single-blind (blinded Independent Reviewer), intra-patient controlled, multicenter post-market study with 80 randomized subjects at up to 15 study centers. After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSureā„¢ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858802
Study type Interventional
Source Intersect ENT
Contact
Status Not yet recruiting
Phase N/A
Start date May 10, 2021
Completion date August 19, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03673956 - Topical Antibiotics in Chronic Rhinosinusitis Phase 1/Phase 2
Recruiting NCT03970655 - Functional Endoscopic Sinus Surgery Study Phase 1/Phase 2
Not yet recruiting NCT04514120 - Alsaleh-Javer Endoscopic Sinus Score (AJESS) System N/A
Recruiting NCT03963648 - NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP N/A
Not yet recruiting NCT04191590 - Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC) N/A
Completed NCT03563521 - Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
Withdrawn NCT03369574 - Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Recruiting NCT04628442 - Tissue Immune Interaction in Nasal Polyposis
Completed NCT04048070 - The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery N/A
Active, not recruiting NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Recruiting NCT03439865 - Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis Early Phase 1
Completed NCT03122795 - Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) N/A
Recruiting NCT04572516 - Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis Phase 3
Completed NCT04595461 - Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery N/A
Recruiting NCT04093193 - Debridement and Functional Endoscopic Sinus Surgery N/A
Not yet recruiting NCT03935828 - Effect of Topical Sinonasal Antibiotics Phase 2
Active, not recruiting NCT03587545 - Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application N/A
Completed NCT03427502 - Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation N/A
Completed NCT04097613 - Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study Early Phase 1
Recruiting NCT04469439 - Impact of Sinus Surgery on Individuals With Cystic Fibrosis