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The PIO II Study of In-office Placement of a Steroid-eluting Sinus Implant

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ClinicalTrials.gov Identifier: NCT02668302
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
Intersect ENT
Information provided by (Responsible Party):
Collin County Ear Nose & Throat

Brief Summary:
Randomized, controlled, double-blinded clinical trial with 40 patients randomized in 1:1 ratio to either treatment (bilateral in-office placement of Propel following ESS) or control (post ESS standard of care) group and followed for 6 months

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Device: Steroid-releasing sinus implant Other: Post-op standard of care Phase 4

Detailed Description:
This prospective, randomized, double-blinded, controlled trial aims to assess the efficacy of a drug-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) compared to the same standard care alone (control). A total of 40 patients will be enrolled at one site and randomized in 1:1 ratio to either the treatment or control group. Patients will return for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination will consist of patient-reported outcomes and endoscopic grading by clinical investigators and an independent blinded reviewer based on video-endoscopy review.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PIO II Study: A Randomized Controlled Blinded Trial to Evaluate the Safety and Efficacy of In-office Placement of a Steroid-eluting Sinus Implant Post-ethmoidectomy
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
Device: Steroid-releasing sinus implant
PROPEL (Intersect ENT, Menlo Park, CA) containing 370μg of mometasone furoate designed for gradual release over 30 days
Other Name: PROPEL

Other: Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Other Name: debridement, irrigation, topical steroids (e.g., Nasonex)

Active Comparator: Control
Post-op standard of care (i.e. debridement, irrigation, and topical steroids)
Other: Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Other Name: debridement, irrigation, topical steroids (e.g., Nasonex)




Primary Outcome Measures :
  1. Inflammation score [ Time Frame: Baseline, 3 months ]
    Change from baseline in the mean inflammation score on 100-mm Visual Analogue Scale (VAS) as determined by an independent blinded review of video-endoscopies


Secondary Outcome Measures :
  1. Percent Ethmoid Sinus Obstruction [ Time Frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer ]
    %Ethmoid Sinus Obstruction on 100 mm VAS assessed by clinical investigators and by an independent reviewer based on video-endoscopy review

  2. Bilateral polyp grade [ Time Frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer ]
    Bilateral polyp grade assessed by clinical investigators and by an independent reviewer based on video-endoscopy review

  3. Coagulum/crusting score [ Time Frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer ]
    Coagulum/crusting score (100-mm VAS) assessed by clinical investigators and by an independent reviewer

  4. Nasal Obstruction/Congestion score [ Time Frame: Baseline, Month 1, 3 & 6 ]
    Nasal Obstruction/Congestion scored by patients

  5. SNOT-22 score [ Time Frame: Baseline, Month 1, 3 & 6 ]
    Sinonasal Outcome Test 22 (SNOT-22) scored by patients

  6. RSI score [ Time Frame: Baseline, Month 1, 3 & 6 ]
    Rhinosinusitis Symptom Inventory (RSI) scored by patients

  7. Need for post-op intervention [ Time Frame: Month 3 & 6 ]
    Need for medical or surgical intervention for ethmoid obstruction/inflammation

  8. Safety measures by recording all adverse events [ Time Frame: Through 6 months ]
    Safety measures by recording all adverse events



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

Inclusion Criteria:

  • Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines, including presence of bilateral ethmoid disease.
  • ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted.

Exclusion Criteria:

  • Known history of intolerance to corticosteroids or an oral steroid-dependent condition.
  • Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

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): NCT02668302


Locations
United States, Texas
Collin County Ear Nose & Throat
Frisco, Texas, United States, 75034
Sponsors and Collaborators
Collin County Ear Nose & Throat
Intersect ENT
Investigators
Principal Investigator: Keith E Matheny, MD Collin County Ear Nose & Throat

Responsible Party: Collin County Ear Nose & Throat
ClinicalTrials.gov Identifier: NCT02668302     History of Changes
Other Study ID Numbers: P2015-09
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Collin County Ear Nose & Throat:
Steroid-eluting implant
Mometasone furoate

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