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

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ClinicalTrials.gov Identifier: NCT02668302
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Intersect ENT
Information provided by (Responsible Party):
Collin County Ear Nose & Throat

Brief Summary:
Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis, Ethmoidal Combination Product: Steroid-eluting sinus implant Other: Post-op standard of care Phase 4

Detailed Description:
This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies.

The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

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
Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
Combination Product: Steroid-eluting sinus implant
PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released 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

Active Comparator: Control
Post-op standard of care, including 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




Primary Outcome Measures :
  1. Inflammation Score [ Time Frame: Change from baseline to Day 90 ]
    Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.



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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
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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