A Clinical Evaluation of PROPEL® Contour Sinus Implant

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-06-20

Brief Summary

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The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

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Detailed Description

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A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.

After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ 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.

Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PROPEL Contour Sinus Implant

Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.

Group Type EXPERIMENTAL

PROPEL Contour Sinus Implant

Intervention Type DEVICE

370 mcg mometasone furoate-coated sinus implant

Balloon Sinus Dilation Alone

Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.

Group Type ACTIVE_COMPARATOR

Balloon Sinus Dilation Alone

Intervention Type PROCEDURE

No PROPEL Contour Sinus Implant

Interventions

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PROPEL Contour Sinus Implant

370 mcg mometasone furoate-coated sinus implant

Intervention Type DEVICE

Balloon Sinus Dilation Alone

No PROPEL Contour Sinus Implant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient is 18 years of age or older.
2. Patient is willing and able to comply with protocol requirements.
3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
4. Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.
5. A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO

Exclusion Criteria

1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \> 2) unless reduced 30 days prior to the baseline procedure
3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
4. Known history of allergy or intolerance to corticosteroids or mometasone furoate.
5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
6. Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.
7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
8. Patients with implantable, body worn devices such as insulin pumps.
9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
11. Active viral illness (e.g., flu, shingles).
12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes