We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation (FRONTIER)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02880514
First Posted: August 26, 2016
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intersect ENT
  Purpose
A prospective, randomized, single-blind, intra-patient controlled, multicenter study

Condition Intervention
Chronic Sinusitis Device: Propel Mini Sinus Implant Procedure: In-office Sinus Dilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Inflammation Score [ Time Frame: Day 30 ]

Secondary Outcome Measures:
  • Inflammation Score [ Time Frame: Day 90 ]
  • Inflammation Score [ Time Frame: Day 180 ]

Estimated Enrollment: 100
Study Start Date: August 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Propel Mini Sinus Implant
Placement of Propel Mini Sinus Implant after a successful in-office balloon dilation of the frontal sinus
Device: Propel Mini Sinus Implant
Active Comparator: In-Office Sinus Dilation
Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) only without implant placement
Procedure: In-office Sinus Dilation

Detailed Description:
This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Patient has provided written informed consent using a form approved by the reviewing IRB.
  • Patient is 18 years of age or older.
  • Patient is willing and able to comply with protocol requirements.
  • Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
  • Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
  • Patient is a candidate for an in-office balloon dilation procedure.
  • In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.

Exclusion Criteria:

  • Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
  • Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
  • Known history of allergy or intolerance to corticosteroids or mometasone furoate.
  • Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
  • Active viral illness (e.g., flu, shingles).
  • Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
  • Currently participating in another clinical trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880514


Locations
United States, California
Sacramento ENT
Sacramento, California, United States, 95815
United States, Florida
ENT Assoicates of South Florida
Boca Raton, Florida, United States, 33487
United States, Georgia
ENT of Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Associated Surgical Specialists
Covington, Louisiana, United States, 70433
United States, Missouri
St. Luke's ENT Specialists
Kansas City, Missouri, United States, 64111
United States, New Mexico
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Madison ENT
New York, New York, United States, 10016
United States, Ohio
Ohio Sinus Institute
Dublin, Ohio, United States, 43016
Sponsors and Collaborators
Intersect ENT
  More Information

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02880514     History of Changes
Other Study ID Numbers: P500-0616
First Submitted: August 18, 2016
First Posted: August 26, 2016
Last Update Posted: March 21, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents