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Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus (PROGRESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT02266810
First received: September 15, 2014
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.

Condition Intervention Phase
Chronic Sinusitis
Device: PROPEL Mini or Nova Sinus Implant.
Procedure: Sinus Surgery only.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Reduction in the need for post-operative interventions [ Time Frame: Day 30 ]
    The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.


Enrollment: 160
Study Start Date: September 2014
Estimated Study Completion Date: July 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROPEL Mini or Nova Sinus Implant
This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
Device: PROPEL Mini or Nova Sinus Implant.
Placement of sinus implant following frontal sinus surgery
Active Comparator: Sinus Surgery only
This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
Procedure: Sinus Surgery only.
Sinus surgery only, without implant placement

Detailed Description:
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each. The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
  • Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.
  • Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.
  • Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side.
  • Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.
  • Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
  • Septoplasty for access to the ostio-meatal complex is permitted.
  • ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.

Exclusion Criteria:

  • Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV)
  • Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition
  • Known history of allergy or intolerance to corticosteroids or mometasone furoate
  • Clinical evidence of acute bacterial sinusitis
  • Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
  • Active viral illness
  • Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease
  • Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period
  • Currently participating in another clinical trial
  • History of insulin dependent diabetes mellitus
  • Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure
  • Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea
  • Current ESS including frontal sinus surgery is aborted for any reason.
  • At least one side is not amenable for implant placement.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02266810

Locations
United States, California
Sacramento Ear, Nose and Throat
Sacramento, California, United States, 95815
Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States, 90503
United States, Connecticut
The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20006
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, New York
Albany ENT and Allergy
Albany, New York, United States, 12206
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Virginia
East Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Timothy L. Smith, MD, MPH Oregon Health and Science University
Principal Investigator: Amber U. Luong, MD, PhD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02266810     History of Changes
Other Study ID Numbers: P500-0514
Study First Received: September 15, 2014
Last Updated: June 7, 2016

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

ClinicalTrials.gov processed this record on May 23, 2017